Reported Nov 23, 2022 · Ongoing
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L,…
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Endo Stitch V-Loc PBT Non-Absorbable ReloadModels VLOCN004LVLOCN006LVLOCN008LVLOCN204LVLOCN206LVLOCN208LVLOCN304LVLOCN306LVLOCN308L
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Barcodes Product as published VLOCN004L20884521072579UDI-DI: 20884521072579 — Lot N0B0834Y VLOCN006L20884521068824UDI-DI: 20884521068824 Lots N0B0660Y N0J0042Y N0J0896Y N1A0931Y N1C0644Y N1L0438Y N2E0205Y N2E0350Y VLOCN008L20884521073606UDI-DI: 20884521073606 Lots N0B0787Y N0E0302Y N1C0706Y N1G0856Y VLOCN204L20884521072609UDI-DI: 20884521072609 Lots N0B0001Y N0E0552Y N0G0568Y N0J0894Y VLOCN206L20884521068831UDI-DI: 20884521068831 Lots N0B0957Y N0G0569Y N0J0933Y N0L0198Y N0M0714Y N1A0932Y N1C0558Y N1C0770Y N1F0047Y N1F0796Y N1G0758Y N1K0184Y N2E0270Y N2E0298Y N9L0954Y VLOCN208L20884521073774UDI-DI: 20884521073774 Lots N0B0772Y N0E0990Y N0G0570Y N0J0870Y N1C0557Y N1F0109Y N1F0132Y N1G0101Y N1J0032Y VLOCN304L20884521072616UDI-DI: 20884521072616 Lots N0B0833Y N0G0487Y VLOCN306L20884521072654UDI-DI: 20884521072654 Lots N0B0851Y N0E0558Y N0G0719Y VLOCN308L20884521073811UDI-DI: 20884521073811 — Lot N0G0324Y - Amount recalled
- 30658
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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