CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report

Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631 recalled by Ethicon

Ethicon is recalling Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631, distributed in 25 states. The recall was initiated on 7 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLCJ948 MCQ529

Quantity recalled372

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-2464-2018
FDA event ID: 80306
Recalling firm: Ethicon, Somerville, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 May 2018
FDA classified: 17 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

7 May 2018	Recall initiated by company
17 Jul 2018	Classified by FDA	+71 days
25 Jul 2018	Published in enforcement report	+8 days

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

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

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

PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

Where it was distributed

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

Arizona California Colorado Florida Georgia Illinois Indiana Kansas Massachusetts Minnesota Missouri North Carolina Nebraska New Jersey New York Ohio Oregon South Carolina South Dakota Tennessee

Questions about this recall

Is Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631 recalled?

Yes. Ethicon recalled Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631 on 7 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2464-2018.

Why was it recalled?

Which lots are affected?

LCJ948 MCQ529

Where was it sold?

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

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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27 Nov 2024Device	CLASS II	Monocryl" (poliglecaprone Suture recalled by Ethicon	Ethicon	Packaging Defects	45 states

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