CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve inte

FDA device recall Z-0092-2023 · posted 2022-10-14 · Open, Classified

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

Action taken

On September 15, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine the product subject to recall. Once customers have returned the completed acknowledgement form to B. Braun Medical Inc., a Customer Support representative will contact the customer with instructions on returning impacted cases. The firm will provide credit and/or replacement of the product based on the customer's needs. For questions, please contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.

Root cause

Process design

Status

Open, Classified

Product code

FPA

Quantity affected

354,200 US; 1,800 OUS

Distribution

Distribution US nationwide, Canada and Saudi Arabia.

Date initiated

2022-09-15

Date posted

2022-10-14

Location

Allentown, PA

Related 510(k) clearances