List No — Class I medical device recall Z-1858-2013
Terminated recall by Hospira Inc., reported 2013-08-14, distributed nationwide. It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture th
| Recall number | Z-1858-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-04-01 |
| Classified | 2013-08-05 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2017-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR |
| Quantity | 3,600 units |
| Lot numbers | 962245H |
Product
List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Reason for recall
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
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-1858-2013. 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.