AM2 PAT, Inc., doing business as Sierra Pre-Filled, Inc., issued a nationwide recall of its Heparin and Normal Saline pre-filled flushes. The products, which were distributed under the brand names Sierra Pre-Filled Inc and B. Braun, may have been contaminated. Consumers and health care professionals are being advised to stop using the products immediately.
Heparin recall details
According to the Food and Drug Administration (FDA), the products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Serratia marcescens which has resulted in patient infections and could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
The Centers for Disease Control and Prevention (CDC) has confirmed growth of Serratia marcescens from one unopened syringe of this product and has also received reports of Serratia marcescens infections associated with the Pre-Filled Normal Saline IV Flush syringes.
The FDA has classified this recall as a Class I recall, the most urgent kind of recall that has a “reasonable probability that use of the product will cause serious injury or death.” Customers were instructed to immediately stop using the product, to quarantine all products in their inventory and to return them to the distributor.
Specific products affected by the recall
The specific products affected by the recall include the following lots and sizes of Pre-Filled Heparin Lock Flush Syringes and Pre-Filled Normal Saline IV Flush Syringes:
| LOT # |
NDC # (*) |
CATALOG # |
Product Brand Name |
| All |
64054-1003-02 |
1003-02 |
Heparin Lock Flush 100units/ml 5ml |
| | 64054-1003-01 |
1003-01 |
Heparin Lock Flush 100units/ml 3ml |
| |
64054-3005-02 |
3005-02 |
Heparin Lock Flush 10units/ml 5ml |
| |
64054-3003-02 |
3003-02 |
Heparin Lock Flush 10units/ml 3ml |
| |
64054-3003-06 |
3003-06 |
Heparin Lock Flush 10units/mL 3ml (6ml syringe) |
| |
64054-3005-06 |
3005-06 |
Heparin Lock Flush 10units/mL 5ml (6ml syringe) |
| |
64054-0910-2 |
0910-12 |
Normal Saline Flush 10ml |
| |
64054-0905-2 |
0905-12 |
Normal Saline Flush 5ml |
| |
64054-0903-2 |
0903-12 |
Normal Saline Flush 3ml |
* NDC-National Drug Code
Additional information
For additional information on the recall, contact the company or the FDA at:
AM2 PAT, Inc. (doing business as Sierra Pre-Filled Inc.)
455 West Depot Street
Angier, NC 27501
919-552-9689
FDA
5600 Fishers Lane,
Rockville, MD 20852-9787
1-888-INFO-FDA (1-888-463-6332)
www.fda.gov/
