Z-1129-2007

Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets

Name: Z-1129-2007 Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets
Creator: Curlin Medical Llc
Published: 2007-02-09
License: https://open.fda.gov/license/

Curlin Medical LLC / initiated 2007-02-09 / Terminated

FDA source

Curlin Medical Llc began a recall of Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets on 2007-02-09. The reason FDA records is "The Administration Sets may leak at the reservior bag". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1129-2007
Status: Terminated
Initiated: 2007-02-09
Posted: 2007-08-07
Terminated: 2008-05-28
Recalling firm: Curlin Medical LLC
Product: Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The Administration Sets may leak at the reservior bag.
FDA 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 in commerce: 25, 280
Distribution: One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109
Product codes and lots: Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716

Product code FPA

K981816Class IICue Ambulatory Volumetric Infusion PumpBecton Dickinson Curlin, LLC / cleared 1998-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)