BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and la

FDA device recall Z-1805-2013 · posted 2013-07-24 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Microbiological identification media may exhibit reduced levels of Vancomycin.

Action taken

The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to contact BD by telephone to receive replacements. If you have any questions, call 410-316-4000.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JSI

Quantity affected

293 cartons

Distribution

Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Date initiated

2013-06-06

Date posted

2013-07-24

Date terminated

2013-09-03

Location

Sparks, MD