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Terminated

Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291

FDA Recall Z-1166-2007 · Posted 2007-08-16

Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2006-09-26
Date Terminated2012-03-22
Product Quantity26,361 units

Reason for Recall

The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

Firm Action

Firm mailed a letter dated September 26, 2006 to notify customers of the recall. The letter advises the product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. Customers are asked that if they have inventory of the lots identified to quarantine these lots and contact your consignees of this recall and return the product immediately for destruction. They are asked to complete and return the attached product inventory summary sheet in the enclosed self-addressed stamped envelope and return product to ICU Medical.

Root Cause

Other

Distribution Pattern

VA, OH, TX, CA, GA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033290TALON INFUSION SET, MODEL IP XXXXIcu Medical, Inc. · 2004-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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