FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
- Recall number
- Z-1166-2007
- Recalling firm
- ICU Medical, Inc.
- Product
- Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
- Status
- Terminated
- Initiated
- 2006-09-26
- Posted
- 2007-08-16
- Terminated
- 2012-03-22
- Reason
- The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
- Root cause
- Other
- 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.
- Quantity
- 26,361 units
- Distribution
- VA, OH, TX, CA, GA
- Lot, serial or model codes
- 414371,414372,414373,433069,433070,453469,453470,453471,488549,488550,488551,488552,488553,488554,
- 510(k) numbers
- K033290
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- 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
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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