Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a sterile Rx single use device, Hospira

FDA device recall Z-1360-2010 · posted 2010-04-15 · Terminated

Recall details

Recalling firm

Hospira Inc.

Reason for recall

Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

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.

Root cause

Component design/selection

Status

Terminated

Product code

FPA

Quantity affected

204,000 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

Date initiated

2009-11-24

Date posted

2010-04-15

Date terminated

2012-01-29

Location

Lake Forest, IL

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