510(k) K012736 ยท FMI Needle, Hypodermic, Single Lumen
MONOJECT SAFETY NEEDLE
| Applicant | Tyco Healthcare, Mansfield MA, US |
| Decision | Substantially Equivalent, Oct 25, 2001 |
| Received | Aug 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2021 | Cardinal Health 200, LLC Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface Terminated |
FMI | None listed |
| Feb 23, 2008 | Tri-State Hospital Supply Corporation Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among othe Terminated |
LRP | None listed |
| Feb 23, 2008 | Tri-State Hospital Supply Corporation Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among oth Terminated |
KDC | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch
Product Code: 8881833010 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch
Product Number: 8881833015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch
Product Number: 8881833110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch
Product Number: 8881833210 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch
Product Number: 8881833215 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch
Product Number: 8881833310 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch
Product Number: 8881833558 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 18G X 1 inch
Product Number: 8881833810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch
Product Number: 8881850010 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch
Product Number: 8881850015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch
Product Number: 8881850110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch
Product Number: 8881850115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1 inch
Product Number: 8881850210 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1 inch
Product Number: 8881850215 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 1 inch
Product Number: 8881850310 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 5/8 inch
Product Number: 8881850358 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 1 inch
Product Number: 8881850510 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 5/8 inch
Product Number: 8881850558 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 18G X 1 inch
Product Number: 8881850810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch
Product Number: 8881850910 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch
Product Number: 8881850915 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 20G X 1.5 inch
Product Number: 8881822015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1 inch
Product Number: 8881822110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1.5 inch
Product Number: 8881822115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 18G X 1 inch
Product Number: 8881822810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 20G X 1.5 inch
Product Number: 8881866015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1 inch
Product Number: 8881866110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1.5 inch
Product Number: 8881866115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 18G X 1 inch
Product Number: 8881866810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch
Product Number: 5551833010 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch
Product Number: 5551833015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch
Product Number: 5551833110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1.5 inch
Product Number: 5551833115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch
Product Number: 5551833210 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch
Product Number: 5551833215 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch
Product Number: 5551833310 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 1 inch
Product Number: 5551833510 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch
Product Number: 5551833558 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch
Product Number: 5551850110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch
Product Number: 5551850115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 1 inch
Product Number: 5551850310 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 5/8 inch
Product Number: 5551850558 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch
Product Number: 5551850915 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 20G X 1.5 inch
Product Number: 5551822015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1 inch
Product Number: 5551822110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1.5 inch
Product Number: 5551822115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch
Product Number: 5551822215 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 18G X 1 inch
Product Number: 5551822810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 20G X 1.5 inch
Product Number: 5551866015 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kenall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1 inch
Product Number: 5551866110 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1.5 inch
Product Number: 5551866115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 18G X 1 inch
Product NUmber: 5551866810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co SAFETY NEEDLE 22GX1'' BULK, Non Sterile
Product Number: 7777850210 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co SAFETY NEEDLE 22X1-1/2 BULK, Non Sterile
Product Number: 7777850215 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co SAFETY NEEDLE 25GX1'' BULK, Non Sterile
Product NUmber: 7777850510 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co SAFETY NEEDLE 18GX1'' BULK Non Sterile
Product Number: 7777850810 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co SAFETY NEEDLE 19GX1'' BULK, Non Sterile
Product Number: 7777850910 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co MAGELLAN 22x1'' TW CLEAR HUB BULK, Non Sterile
Product Number: 7777851210 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co MAGELLAN 23x1'' TW CLEAR HUB BULK, Non Sterile
Product Number: 7777851310 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co MAGELLAN 25x5/8 TW CLEAR HUB BULK, Non Sterile
Product Number: 7777851558 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Adult Lumbar Puncture Tray with Safety Components 18G x 3.5 inch
Product Code: 1017 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Adult Lumbar Puncture Tray with Safety Components 20G x 3.5 inch
Product Code: 1032 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Pediatric Lumbar Puncture Tray with Safety Components 22G x 3.5 inch
Product Number: 1048 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch
Product Number: 7039 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch, with manometer
Product Number: 7500 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Amniocentesis Tray with Safety Components
Product Number: 97051 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Rosenthall needle
Product Number: 8881846169 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 3.5 inch needle
Product Number: 8881847027 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 16G x 4 inch
Product Number: 8881847035 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch
Product Number: 8881847084 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 11G x 4 inch
Product Number: 8881847118 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 1 7/8 inch needle
Product Number: 8881847167 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray without Bone Marrow needle
Product Number: 8881847993 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Argyle Pneumothorax Procedure Tray with Safety Components
Product Number: 8888567032 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 11G x 4 inch Bone Marrow needle only
Product Number: SC3411 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 16G x 5 inch Bone Marrow needle plus ''I'' type Sternal / Iliac needle
Product Number: SC4508 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 16G x 4 inch Bone Marrow needle plus ''I'' type Sternal / Iliac needle
Product Number: SC4511 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 11G x 4 inch Bone Marrow needle plus ''I'' type Sternal / Iliac needle
Product Number: SCE3411 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Basic Tray with Safety Components, 11G x 4 inch Bone Marrow needle only
Product Number: SCE4511 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Thoracentesis Tray with Safety Components 16G needle
Product Number: 5014 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Thoracentesis Tray with Safety Components 14G catheter & 17G needle
Product Number: 5016 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall TURKEL Safety Thoracentesis Tray 8F x 3.5 inch
Product Number: 566059 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall TURKEL Safety Thoracentesis Tray 8F x 5 inch
Product Number: 566075 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 4 inch needle
Product Number: 8881847019 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Argyle TURKEL Safety Paracentesis Procedure Tray
Product Number: 8888568006 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 18G X3.5 inch
Product Number: 8888713115 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 20G X3.5 inch
Product Number: 8888713123 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 22G X3.5 inch
Product Number: 8888713131 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Pediatric Lumbar Puncture Tray with Safety Components 22G X2.5 inch
Product Number: 8888714113 Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Infant Lumbar Puncture Tray with Safety Components 22G X1.5 inch
Product Number: 8888715110 Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.