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PROLENE recallZ-1096-2025 · Ethicon, LLC · initiated Dec 20, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

FDA root cause category: Process control

What the company is doing

On 12/20/2024, Johnson & Johnson Med Tech mailed recall notices to Operating Room Supervisors, Materials Management Personnel, Chief of Surgery, and distributors who were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3) Contact Sedgwick at 888-548-8526 to arrange affected product return. 4) Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 5) Complete and return the Business Reply Form via email to [email protected] If you have additional questions regarding this communication contact the firm's Resource Department at 1-877-ETHICON (1-877-384-4266) open Monday through Friday, 8:00 AM to 5:00 PM ET.

Recall details

Recall number
Z-1096-2025
Status
Open, Classified
Initiated by the company
Dec 20, 2024
Posted by the FDA
Feb 4, 2025
Recalling firm
Ethicon, LLC
Quantity
15,948
Product code
GAW
FDA submissions
K133356
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.

Product description

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

Code information (models, lots, serial numbers)

REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029)

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

337 devices cleared under K133356 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96127).

Sources and updates

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