BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

FDA device recall Z-1747-2015 · posted 2015-06-10 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.

Action taken

BD Diagnostic Systems sent an Urgent Product Recall letter dated December 2014 to all affected customers. Recall notification was initiated on November 21, 2014, the notification was sent by fax and letters by UPS. Customer notification for the expansion of the recall was initiated on December 18, 2014, the notification was sent by fax and letters by UPS. For questions regarding this recall call 800-638-8663.

Root cause

Process control

Status

Terminated

Product code

N/A

Quantity affected

92,710 units

Distribution

US Nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT

Date initiated

2014-11-21

Date posted

2015-06-10

Date terminated

2016-01-07

Location

Sparks, MD