FDA Medical Device Recalls (openFDA)
Hospira Inc.: Symbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced reseal ports, Option-Lok, Latex-Free, Non-DEHP, 130 in. (330 cm), 15 drops/mL; a sterile Rx single use device; Hospira Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; product 196750428, list number 19675-28
- Recall number
- Z-1063-2010
- Recalling firm
- Hospira Inc.
- Product
- Symbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced reseal ports, Option-Lok, Latex-Free, Non-DEHP, 130 in. (330 cm), 15 drops/mL; a sterile Rx single use device; Hospira Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; product 196750428, list number 19675-28
- 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
- 32,688 sets
- Distribution
- Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
- Lot, serial or model codes
- Lots numbers: 631945H, 641945H, 661415H and 671845H.
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28