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Terminated

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

FDA Recall Z-1236-2007 · Posted 2007-09-20

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeNGT
Date Initiated2007-07-30
Date Terminated2008-04-01
Product Quantity1,292,520 units

Reason for Recall

Particulate matter in product.

Firm Action

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.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002142SALINE IV FLUSH SYRINGEEmt-Rx · 2002-01-28

Official Source

View FDA Recall →

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

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