BD MaxGuard Extension Set, REF: ME1069
Recall
- Recall Number
- Z-1753-2022
- Event Number
- 90707
- Firm
- CAREFUSION
- FEI Number
- 3012410077
- Product Code
- FPA
- Status
- Open, Classified
- Root Cause
- Error in labeling
- Initiated
- August 1, 2022
- Posted
- September 13, 2022
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD MaxGuard Extension Set, REF: ME1069
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
On 8/1/22 Correction-recall notices were emailed or mailed to customers and distributors who were asked to do the following: 1) Destroy affected devices following your institutions process for destruction. 2) Share this notification with all users within your facility network to ensure all are aware. The correction-recall notice should also be shared with any organization where the potentially affected product has been transferred. 3) Complete and return the response form. In addition distributors were informed that the recalling firm plans to notify all affected customers directly so they were asked to provide a a list of customers who received affected devices. The distributor response form has a check box if the distributor declines to provide a customer list to the recalling firm because they have notified customers about the correction-recall. A copy of the customer communication was provided to the distributor. If customers or distributors require additional assistance they are aske to call 1-844-823-5433, Mon-Fri 8:00 AM - 5:00 PM CT or [email protected]
US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN
3,500