ClearanceBrief
510(k) K012736 ยท FMI Needle, Hypodermic, Single Lumen

MONOJECT SAFETY NEEDLE

ApplicantTyco Healthcare, Mansfield MA, US
DecisionSubstantially Equivalent, Oct 25, 2001
ReceivedAug 16, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012736

DateFirm and productCodeLinked 510(k)
Feb 9, 2021Cardinal 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
FMINone listed
Feb 23, 2008Tri-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
LRPNone listed
Feb 23, 2008Tri-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
KDCNone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch Product Code: 8881833010
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 8881833015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch Product Number: 8881833110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch Product Number: 8881833210
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 8881833215
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch Product Number: 8881833310
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch Product Number: 8881833558
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 18G X 1 inch Product Number: 8881833810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch Product Number: 8881850010
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch Product Number: 8881850015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 8881850110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 8881850115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1 inch Product Number: 8881850210
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1 inch Product Number: 8881850215
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 1 inch Product Number: 8881850310
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 5/8 inch Product Number: 8881850358
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 1 inch Product Number: 8881850510
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 5/8 inch Product Number: 8881850558
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 18G X 1 inch Product Number: 8881850810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch Product Number: 8881850910
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch Product Number: 8881850915
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 8881822015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1 inch Product Number: 8881822110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 8881822115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 18G X 1 inch Product Number: 8881822810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 8881866015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1 inch Product Number: 8881866110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 8881866115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 18G X 1 inch Product Number: 8881866810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch Product Number: 5551833010
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 5551833015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch Product Number: 5551833110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 5551833115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch Product Number: 5551833210
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551833215
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch Product Number: 5551833310
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 1 inch Product Number: 5551833510
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch Product Number: 5551833558
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 5551850110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 5551850115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 1 inch Product Number: 5551850310
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 5/8 inch Product Number: 5551850558
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch Product Number: 5551850915
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 5551822015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1 inch Product Number: 5551822110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 5551822115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551822215
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 18G X 1 inch Product Number: 5551822810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 5551866015
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kenall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1 inch Product Number: 5551866110
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 5551866115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 18G X 1 inch Product NUmber: 5551866810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
SAFETY NEEDLE 22GX1'' BULK, Non Sterile Product Number: 7777850210
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
SAFETY NEEDLE 22X1-1/2 BULK, Non Sterile Product Number: 7777850215
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
SAFETY NEEDLE 25GX1'' BULK, Non Sterile Product NUmber: 7777850510
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
SAFETY NEEDLE 18GX1'' BULK Non Sterile Product Number: 7777850810
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
SAFETY NEEDLE 19GX1'' BULK, Non Sterile Product Number: 7777850910
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
MAGELLAN 22x1'' TW CLEAR HUB BULK, Non Sterile Product Number: 7777851210
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
MAGELLAN 23x1'' TW CLEAR HUB BULK, Non Sterile Product Number: 7777851310
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
MAGELLAN 25x5/8 TW CLEAR HUB BULK, Non Sterile Product Number: 7777851558
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Adult Lumbar Puncture Tray with Safety Components 18G x 3.5 inch Product Code: 1017
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Adult Lumbar Puncture Tray with Safety Components 20G x 3.5 inch Product Code: 1032
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Pediatric Lumbar Puncture Tray with Safety Components 22G x 3.5 inch Product Number: 1048
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch Product Number: 7039
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch, with manometer Product Number: 7500
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Amniocentesis Tray with Safety Components Product Number: 97051
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Rosenthall needle Product Number: 8881846169
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 3.5 inch needle Product Number: 8881847027
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 16G x 4 inch Product Number: 8881847035
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch Product Number: 8881847084
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 11G x 4 inch Product Number: 8881847118
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 1 7/8 inch needle Product Number: 8881847167
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray without Bone Marrow needle Product Number: 8881847993
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Argyle Pneumothorax Procedure Tray with Safety Components Product Number: 8888567032
Terminated
FMINone listed
Nov 2, 2004Kendall 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
FMINone listed
Nov 2, 2004Kendall 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
FMINone listed
Nov 2, 2004Kendall 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
FMINone listed
Nov 2, 2004Kendall 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
FMINone listed
Nov 2, 2004Kendall 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
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Thoracentesis Tray with Safety Components 16G needle Product Number: 5014
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Curity Thoracentesis Tray with Safety Components 14G catheter & 17G needle Product Number: 5016
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall TURKEL Safety Thoracentesis Tray 8F x 3.5 inch Product Number: 566059
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Kendall TURKEL Safety Thoracentesis Tray 8F x 5 inch Product Number: 566075
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 4 inch needle Product Number: 8881847019
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Argyle TURKEL Safety Paracentesis Procedure Tray Product Number: 8888568006
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 18G X3.5 inch Product Number: 8888713115
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 20G X3.5 inch Product Number: 8888713123
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 22G X3.5 inch Product Number: 8888713131
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Pediatric Lumbar Puncture Tray with Safety Components 22G X2.5 inch Product Number: 8888714113
Terminated
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Infant Lumbar Puncture Tray with Safety Components 22G X1.5 inch Product Number: 8888715110
Terminated
FMINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.