FDA Recall Open, Classified

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Recall: Z-1057-2022 · Initiated March 8, 2022

Recall

Recall Number
Z-1057-2022
Event Number
89952
Firm
SIMPLIVIA HEALTHCARE LTD. NORTH IND. ZONE, (MIGADA PLANT) NORTH IND. ZONE PoBOX
FEI Number
3002807615
Product Code
ONB
Status
Open, Classified
Root Cause
Equipment maintenance
Initiated
March 8, 2022
Address
888 Kiryat Shmona Israel

Description

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Reason

Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

Action

The recall notice and acknowledgement form dated 08 March 2022 were sent under B. Braun cover letter on 03/10/2022 via Certified USPS mail. Distributors are to forward the recall notification to customers to extend the recall to the end user/customer level. Identify current inventory, cease use and quarantine product subject to recall. Do not destroy, return product and complete the Product Removal Acknowledgement form. If you are a direct consignee of B. Braun Medical Inc. a B. Braun customer service representative will contact you to arrange for return of product. If you have received this recall notice from a customer of B. Braun, please return product to your local distributor to ensure proper credit and replacement of material. OnGuard Spike Port Adaptor may be used as an alternative to replace the OnGuard2 Bag Adaptor SP. If you have questions contact Simplivia: Shay Shaham, Sunday to Friday, 08:00 to 19:00 (GMT+2) at the following phone number: 97246908826.

Distribution

Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.

Quantity

293,520