Recall Z-0986-2024 ยท OCW Endoscopic Tissue Approximation Device
Covidien LP
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
| Date | Feb 6, 2024 (initiated Nov 16, 2023) |
| Status | Open, Classified |
| Reason | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility |
| Root cause | Process control |
| Action | Medtronic issued Urgent Medical Device Recall Letter and Customer Acknowledgement Form to each consignee via mail beginning 16 November 2023. Letter states reason for recall, health risk and action to take: Identify and quarantine all unused and non-expired affected lot N3J1860Y of the ModelABSTACK30 AbsorbaTack" Absorbable Fixation Device listed above. See attachment A forguidance on identifying potentially affected devices. "Return all unused product from the affected lot in your inventory to Medtronic. Please contactrs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Author |
| Quantity | 54 units |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, IL, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES Covidien, May 14, 2009 |