Recall Z-1626-2014
Hospira Inc. · initiated March 25, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
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
FDA-determined cause: Process design
Action taken
Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated March 25, 2014 to all affected customers. The letter included instructions for the direct accounts to: 1) check their inventories and quarantine any of the affected products; 2) complete and return the attached reply form to the fax number or e-mail address on the form; 3) inform potential users of these products of this recall; 4) return the affected products to Stericycle using the labels provided with the letter (additional labels or reply forms can be obtained by calling Stericycle at 877-377-5128, Monday - Friday, 8:00 AM - 5:00 PM EST); and, 5) if the products were further distributed, notify those customers and request that they contact Stericycle at 877-377-5128 (Monday - Friday, 8:00 AM - 5:00 PM EST). An updated URGENT MEDICAL DEVICE RECALL letter dated March 28, 2014 was sent to all affected customers. The letter contained instructions similar to those found in the March 25, 2014 letter.
Details
- Recall number
- Z-1626-2014
- Initiated
- March 25, 2014
- Posted by FDA
- May 16, 2014
- Terminated
- December 6, 2016
- Product code
- GBX – Catheter, Irrigation
- Quantity
- 167,574 sets
- Distribution
- Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait…
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1623-2014 Class II | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1624-2014 Class II | LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1625-2014 Class II | LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1627-2014 Class II | LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |