FDA Device recall Z-3107-2017
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, I…
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, I… by Cardinal Health 200, citing the firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3107-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-01 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
Reason
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
Identifiers
| code_info | CATALOG # CS WO (LOT)_# 05A7593 407625 05A7593 412059 05A7593 420879 09-4733A 503927 09-4733A 611913 13-A3858B 58…CATALOG # CS WO (LOT)_# 05A7593 407625 05A7593 412059 05A7593 420879 09-4733A 503927 09-4733A 611913 13-A3858B 588354 13-A3858B 619381 13-A3858B 647955 22-0758B 412013 22-0758B 414835 26-2503 485950 26-2503 604487 26-2503 643270 26-2503 673080 26-2927 407083 26-2927 416194 26-9079A 594214 26-9079A 621261 26-9079A 647250 26-9079A 672502 26-9079A 715637 26A2503 642655 26A2503 655681 26A2503 697266 26A6667B 417410 26B4610B 412369 26B4610B 419333 26-LP1SF 408438 26-LP1SF 408438 26-LP1SF 414819 26-LP1SF 418497 26-LP1SFDF 583577 26-LP1SFDF 595028 26-LP1SFDF 599316 26-LP1SFDF 617603 26-LP1SFDF 620380 26-LP1SFDF 671133 26-LP2SF 412374 26-LP2SF 417223 26-LP2SF 423100 26-LP2SF 423100 26-LP2SFDF 592704 26-LP2SFDF 617604 26-LP3SF 408287 26-LP3SF 412353 26-LP3SFDF 577939 26-LP3SFDF 605345 26-LP4SF 422101 26-LP6SF 419814 26-LP6SF 424210 27-9386A 376178 27-9386A 408314 27-9386A 418220 27-9386A 419957 27-9386A 424866 27-MY1SF 408933 27-MY1SF 414 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3107-2017%22
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