FDA Medical Device Recalls (openFDA)
Hospira Inc.: LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11235-03
- Recall number
- Z-0133-06
- Recalling firm
- Hospira Inc.
- Product
- LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11235-03
- Status
- Terminated
- Initiated
- 2005-09-29
- Posted
- 2005-11-15
- Terminated
- 2007-11-29
- Reason
- Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Root cause
- Other
- Action
- Hospira sent product recall letters dated 9/29/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possibility of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lots, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
- Quantity
- 22,248 sets
- Distribution
- Nationwide, including Puerto Rico, and internationally to Australia, Mexico, Canada, Taiwan and Saudi Arabia.
- Lot, serial or model codes
- list 11235-03, lots 270735H, 271635H
- 510(k) numbers
- ["K830014","K865060","K920736","K941214"]
- PMA numbers
- not on file
- Product code
- BRZ
- 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