FDA Medical Device Recalls (openFDA)
Curlin Medical Llc: Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
- Recall number
- Z-1129-2007
- Recalling firm
- Curlin Medical Llc
- Product
- Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
- Status
- Terminated
- Initiated
- 2007-02-09
- Posted
- 2007-08-07
- Terminated
- 2008-05-28
- Reason
- The Administration Sets may leak at the reservior bag.
- Root cause
- Other
- Action
- A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels. A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels.
- Quantity
- 25, 280
- Distribution
- One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109
- Lot, serial or model codes
- Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716
- 510(k) numbers
- ["K981816"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3002936294
- Firm city
- Huntington Beach
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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