ICU Medical, Inc. Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
414371, 414372, 414373, 433069, 433070, 453469, 453470, 453471, 488549, 488550, 488551, 488552, 488553, 488554
Products Sold
414371,414372,414373,433069,433070,453469,453470,453471,488549,488550,488551,488552,488553,488554,
ICU Medical, Inc. is recalling Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 due to The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, OH, TX, VA
Page updated: Jan 10, 2026