LATEX-FREE — Class II medical device recall Z-1623-2014
Terminated recall by Hospira Inc., reported 2014-05-28, distributed nationwide. The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the s
| Recall number | Z-1623-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-03-25 |
| Classified | 2014-05-16 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2016-12-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BB, CA, CR, DO, HK, KW, SA |
| Quantity | 42,292 sets |
| Reason classes | sterility |
| Lot numbers | 16119NS, 17186NS, 21134NS, 25129NS |
Product
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
Reason for recall
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
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-1623-2014. 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.