510(k) K854547 ยท FMI Needle, Hypodermic, Single Lumen
MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
| Applicant | Sherwood Medical Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 4, 1986 |
| Received | Nov 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2020 | Cardinal Health 200, LLC Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patien Terminated |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 14 G x 1-1/2"
Item code: 8881200011 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle
Item code: 8881200029 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 16 G x 1-1/2"
Item code: 8881200037 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 16 G x 1-1/2"
Item code:8881200045 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 18 G x 1-1/2"
Item code: 8881200078 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 27 G x 1-1/4"
Item code: 8881200508 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk
Item code: 8881200664 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2"
Item code: 8881201456 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2"
Item code: 8881201498 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2
Item code: 8881201522 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2
Item code: 8881201548 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2
Item code: 8881201654 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm)
Item code: 8881202314 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm)
Item code: 8881202322 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm)
Item code: 8881202355 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm)
Item code: 8881202363 Completed |
FMI | None listed |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm)
Item code: 8881202389 Completed |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.