BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene

FDA device recall Z-1398-2024 · posted 2024-03-29 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results

Action taken

BD issued URGENT: Medical Device Product Correction Product Removal letter on 2/29/24 via courier service via tracked letter and/or e-mail. Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood. 3. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. BD will issue product replacements following receipt of the completed Customer Response Form. Contact: North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com Product Advisory, Recall Questions, Product Complaints, Technical Questions

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LON

Quantity affected

11,800 eaches

Distribution

Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.

Date initiated

2024-02-29

Date posted

2024-03-29

Location

Sparks, MD

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