Latex-free, Nitroglycerin Primary I.V. Pump Set, convertible pin, 107 inch with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11993-78.
This recall has been terminated (originally issued April 15, 2010).
- Company
- Hospira Inc.
- Recall Initiated
- November 24, 2009
- Posted
- April 15, 2010
- Terminated
- January 29, 2012
- Recall Number
- Z-1345-2010
- Quantity
- 16,944 sets
- Firm Location
- Lake Forest, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
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 / Code Info
Lot numbers: 551275H, 551755H, 590505H, 600665H, and 621375H.
Root Cause
Component design/selection
Action Taken
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.