Z-1236-2007

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

Name: Z-1236-2007 Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton
Creator: B. Braun Medical, Inc.
Published: 2007-07-30
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2007-07-30 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton on 2007-07-30. The reason FDA records is "Particulate matter in product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1236-2007
Status: Terminated
Initiated: 2007-07-30
Posted: 2007-09-20
Terminated: 2008-04-01
Recalling firm: B Braun Medical Inc
Product: Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Particulate matter in product.
FDA root cause: Other
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.
Quantity in commerce: 1,292,520 units
Distribution: The products were shipped to distributors nationwide.
Product codes and lots: 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.

Product code NGT

K002142Class IISaline IV Flush SyringeEmt-Rx / cleared 2002-01-28

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)