FDA Device recall Z-1626-2014
LATEX-FREE
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of LATEX-FREE by Hospira, citing 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 F….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1626-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-25 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | US |
Product
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
Reason
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
Identifiers
| code_info | List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 2412…List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 24120NS, 25134NS, 25211NS, 27112NS, 28273NS, 28274NS, 29098NS, 31040NS, 32296NS, 33142NS, 34143NS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1626-2014%22
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