Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for
FDA device recall Z-1183-2023 · posted 2023-02-27 · Open, Classified
Recall details
- Recalling firm
- Covidien, LP
- Reason for recall
- Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
- Action taken
- Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter on Jan 11, 2023, to Risk Manager/Healthcare Professional/Distributor via UPS 2-day delivery. For outside United States. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Identify and quarantine all unused and non-expired product from the affected lot (PVE0194M) of Parietex" Composite Mesh. If Parietex" Composite Mesh with collagen film on the wrong side is encountered in the operating room setting, please discard the product and use additional, correct mesh product instead. In the event it is determined by a medical facility that an affected product was implanted during a procedure, that facility should follow its medical record management procedures to ensure that this recall condition is properly noted for that procedure and documented to ensure traceability. Please complete the enclosed Customer Confirmation Form (even if your account no longer has unused and non-expired product from the affected lot (PVE0194M) on hand) and email to rs.gmbfcamitg@medtronic.com. Return all unused and non-expired product from the affected lot in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888, Option 2. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product within the specified lot has been transferred or distributed. Shipping and Return Instructions: For product purchased directly from Medtronic, please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Credit or Replacement for the returned affected product will be issued based on the RGA number. If purchased from a distributor, contact your distributor directly
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FTL
- Quantity affected
- 53 units
- Distribution
- US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom.
- Date initiated
- 2023-01-11
- Date posted
- 2023-02-27
- Location
- North Haven, CT
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