Recall Z-0200-2023
Covidien, LP · initiated September 28, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
Codes / lots: Model VLOCA004L UDI-DI: 20884521068084 Lots N1G0268Y N9M0756Y Model VLOCA006L UDI-DI: 20884521068091 Lots N0D0586Y N0H0178Y N1A0817Y N1B0531Y N1E0104Y N1E0747Y N1F0714Y N1H0583Y N1J0848Y N2D0068Y N2D0077Y N2D0240Y Model VLOCA008L UDI-DI: 20884521068275 Lots N0A0577Y N0C0316Y N0D0001Y N0D0106Y N0D0397Y N0D0398Y N0E0682Y N0F0368Y N0F0758Y N0F0969Y N0G0972Y N0J1022Y N0J1023Y N0K0723Y N0K1031Y N0L0127Y N0L0128Y N0M0360Y N0M0513Y N1A0199Y N1A0660Y N1A0816Y N1A0958Y N1B0110Y N1B0750Y N1C0088Y N1C0398Y N1C0495Y N1D0528Y N1D0697Y N1D0853Y N1E0102Y N1E0103Y N1F0035Y N1F0182Y N1G0107Y N1G0404Y N1G0628Y N1H0234Y N1H0677Y N1J0440Y N1K0248Y N1K0306Y N1K0867Y N1L0592Y N1L0766Y N1M0720Y N1M0731Y N2A0468Y N2B0095Y N2B0188Y N2B0289Y N2C0008Y N2C0009Y N2C0032Y N2C0495Y N2C0683Y N2D0813Y N2D0814Y N9K1167Y N9K1169Y N9L0102Y N9L0103Y N9L0503Y N9L0966Y N9M0077Y Model VLOCA204L UDI-DI: 20884521068114 Lots N0C0212Y N0J0294Y Model VLOCA206L UDI-DI: 20884521068121 Lots N0C0307Y N0D0105Y N0D0326Y N0D0327Y N0D0587Y N0E0718Y N0E0979Y N1A0502Y N1E0748Y N1F0701Y N1F0915Y N1G0759Y N1H0058Y N1H0803Y N1K0185Y N1M0276Y N2C0524Y N2D0233Y N2D0444Y N2D0445Y Model VLOCA208L UDI-DI: 20884521068282 Lots N0A0201Y…
Reason for recall
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-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0200-2023
- Initiated
- September 28, 2022
- Posted by FDA
- November 11, 2022
- Product code
- GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
- Quantity
- 117978
- 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…
- Recalling firm
- Covidien, LP, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0201-2023 Class II | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L…Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s)… | 09/28/2022Open, Classified |