Recalls / —

—#55362

Product

Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.

FDA product code

NGT — Saline, Vascular Access Flush

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K002142

Affected lot / code info

Item number 531587. Lot numbers 070507SFR exp 5/09, 070523SFR exp 5/09 070529SFR exp 6/09, 070601SFR exp 6/09, 070605SFR exp 6/09, 070608SFR exp 6/09, 070613SFR exp 6/09, 070618SFR exp 6/09, 070620SFR exp 6/09, and 070625SFR exp 6/09.

Why it was recalled

Particulate matter in product.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

The products were shipped to distributors nationwide.

Timeline

Recall initiated

2007-07-30

Posted by FDA

2007-09-20

Terminated

2008-04-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #55362. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.