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Terminated

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

FDA Recall Z-1129-2007 · Posted 2007-08-07

Recalling FirmCurlin Medical Llc
Recall StatusTerminated
Product CodeFPA
Date Initiated2007-02-09
Date Terminated2008-05-28
Product Quantity25, 280

Reason for Recall

The Administration Sets may leak at the reservior bag.

Firm 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.

Root Cause

Other

Distribution Pattern

One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981816CUE AMBULATORY VOLUMETRIC INFUSION PUMPBecton Dickinson Curlin, LLC · 1998-12-04

Official Source

View FDA Recall →

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

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