CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

BBL Port A Cul tubes with Swabs Sterile Pack recalled

Becton Dickinson & is recalling BBL Port A Cul tubes with Swabs Sterile Pack, distributed nationwide in the US. The recall was initiated on 21 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart/Cat No. Lot / Serial No.Date of Mfr Exp. Date 221607 4067181 3/19/2014 3/5/2015 221607 4083274 4/3/2014 3/20/2015 221607 4124706 5/9/2014 4/24/2015 221607 4127564 5/22/2014 5/1/2015 221607 4170891 7/8/2014 6/19/2015 221607 4006235 2/18/2014 12/26/2014 221607 4028420 2/19/2014 1/21/2015

Quantity recalled92,710 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1747-2015
FDA event ID: 69954
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2014
FDA classified: 10 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

21 Nov 2014	Recall initiated by company
10 Jun 2015	Classified by FDA	+201 days
17 Jun 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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, WA, WI, WV, and WY.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is BBL Port A Cul tubes with Swabs Sterile Pack recalled?

Yes. Becton Dickinson & recalled BBL Port A Cul tubes with Swabs Sterile Pack on 21 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-1747-2015.

Why was it recalled?

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

Which lots are affected?

Part/Cat No. Lot / Serial No.Date of Mfr Exp. Date 221607 4067181 3/19/2014 3/5/2015 221607 4083274 4/3/2014 3/20/2015 221607 4124706 5/9/2014 4/24/2015 221607 4127564 5/22/2014 5/1/2015 221607 4170891 7/8/2014 6/19/2015 221607 4006235 2/18/2014 12/26/2014 221607 4028420 2/19/2014 1/21/2015

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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