FDA Medical Device Recalls (openFDA)
Hospira Inc.: Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160980728, REF 16098.
- Recall number
- Z-1061-2010
- Recalling firm
- Hospira Inc.
- Product
- Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160980728, REF 16098.
- Status
- Terminated
- Initiated
- 2009-11-24
- Posted
- 2010-03-09
- Terminated
- 2012-01-29
- Reason
- Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Root cause
- Process control
- Action
- Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.
- Quantity
- 110,640 sets
- Distribution
- Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
- Lot, serial or model codes
- Lot numbers: 782325H, 791295H, and 791345H.
- 510(k) numbers
- K041550
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06