Presource — Class II medical device recall Z-3107-2017
Terminated recall by Cardinal Health 200, LLC, reported 2017-09-13, distributed nationwide. The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles.
| Recall number | Z-3107-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2017-08-01 |
| Classified | 2017-09-05 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2019-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 184,102 kits |
| Reason classes | specification failure |
| Lot numbers | 05A7593, 09-4733A, 13-A3858B, 22-0758B, 26-2503, 26-2927, 26-9079A, 26-LP1SF, 26-LP1SFDF, 26-LP2SF, 26-LP2SFDF, 26-LP3SF, 26-LP3SFDF, 26-LP4SF, 26-LP6SF, 26A2503, 26A6667B, 26B4610B, 27-9386A, 27-MY1SF, 27-MY1SFV, 28-2961A, 28-6031A, 28-AR1SF, 28-AR1SFDF, 29-AM1SF, 30-9211A, 30-CE11SDF, 30-CE11SF, 30-CE16SF, 30-CE18SF, 30-CE1SF, 30-CE1SFDF, 30-CE2SFA, 30-CE2SFAF, 30-CE3SFDF, 30-CE5CSDF, 31-0023A, 31-7479, 31-7479A and 219 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3107-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.