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V-Loc recallZ-0201-2023 · Covidien, LP · initiated Sep 28, 2022

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 Covidien, LP 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

Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

FDA root cause category: Process control

What the company is doing

Beginning 28-September-2022 communications to all affected consignees began. Consignees are asked to return any affected product they may have, forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

Recall details

Recall number
Z-0201-2023
Status
Open, Classified
Initiated by the company
Sep 28, 2022
Posted by the FDA
Nov 11, 2022
Recalling firm
Covidien, LP
Quantity
30658
Product code
GAM
FDA submissions
K111442
Distribution
Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungary Ireland Israel Italy Jordan Kazakhstan Kuwait Lithuania Luxembourg Mexico Netherlands New Zealand Norway Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom

Product description

Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model VLOCN004L UDI-DI: 20884521072579 Lot N0B0834Y Model VLOCN006L UDI-DI: 20884521068824 Lots N0B0660Y N0J0042Y N0J0896Y N1A0931Y N1C0644Y N1L0438Y N2E0205Y N2E0350Y Model VLOCN008L UDI-DI: 20884521073606 Lots N0B0787Y N0E0302Y N1C0706Y N1G0856Y Model VLOCN204L UDI-DI: 20884521072609 Lots N0B0001Y N0E0552Y N0G0568Y N0J0894Y Model VLOCN206L UDI-DI: 20884521068831 Lots N0B0957Y N0G0569Y N0J0933Y N0L0198Y N0M0714Y N1A0932Y N1C0558Y N1C0770Y N1F0047Y N1F0796Y N1G0758Y N1K0184Y N2E0270Y N2E0298Y N9L0954Y Model VLOCN208L UDI-DI: 20884521073774 Lots N0B0772Y N0E0990Y N0G0570Y N0J0870Y N1C0557Y N1F0109Y N1F0132Y N1G0101Y N1J0032Y Model VLOCN304L UDI-DI: 20884521072616 Lots N0B0833Y N0G0487Y Model VLOCN306L UDI-DI: 20884521072654 Lots N0B0851Y N0E0558Y N0G0719Y Model VLOCN308L UDI-DI: 20884521073811 Lot N0G0324Y

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

9 devices cleared under K111442 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 90892).

Sources and updates

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