FDA Medical Device Recalls (openFDA)
Hospira Inc.: Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and Pressure-Activated Anti-Siphon Valve, convertible pin, 109 inch with CLAVE and OPTION-LOK for use OMNI-FLOW Medication Management System, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12162-01.
- Recall number
- Z-1356-2010
- Recalling firm
- Hospira Inc.
- Product
- Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and Pressure-Activated Anti-Siphon Valve, convertible pin, 109 inch with CLAVE and OPTION-LOK for use OMNI-FLOW Medication Management System, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12162-01.
- Status
- Terminated
- Initiated
- 2009-11-24
- Posted
- 2010-04-15
- Terminated
- 2012-01-29
- Reason
- Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Root cause
- Component design/selection
- Action
- Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.
- Quantity
- 181,296 sets
- Distribution
- Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
- Lot, serial or model codes
- Lot numbers: 520665H, 530685H, 530695H, 530705H, 532335H, 532345H, 532355H, 542145H, 550095H, 560635H, 560645H, 560655H, 570545H, 570555H, 571005H, 571445H, 580515H, 580525H, 600335H, 610775H, 610995H, 620755H, 620765H, and 620775H.
- 510(k) numbers
- ["K832755"]
- 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