PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Recall
- Recall Number
- Z-2146-2024
- Event Number
- 94643
- Firm
- Ethicon, Inc.
- FEI Number
- 3017102971
- Product Code
- GAM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 10, 2024
- Posted
- June 14, 2024
- Address
- 1000 Route 202, Raritan, NJ, 08869-1425
Description
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Erhicon issued Urgent: Medical Device Recall (Removal) letter on May 10, 2024 to US Distributors, primary and secondary consignees via UPS second day. Ethicon Johnson & Johnson affiliates in EMEA, LATAM, APAC and Canada will be contacting all their impacted primary and secondary consignees and/or end customers. Letter states reason for recall, health risk and action to take: 1. Determine whether you have inventory of the lots listed in Attachment 1. If so, you may " Option 1: Remove the first package of suture from a complete box, i. Quarantine and return it for credit. You may use the remaining 35 sutures in accordance with the IFU. (See Figure 2 below for location of first package) OR ii. Examine the first package of a complete box prior to use. Quarantine and return this unit if a packaging defect is identified. (See Figure 2 below for location of first package). If no defect is found, the product and remaining 35 sutures in the box may be used accordance with the IFU. OR "Option 2: Quarantine all product in scope and return all inventory for credit. Please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 800-901-0335 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused sutures with holes in the primary packaging subject to this recall that are in inventory immediately. To receive credit for items returned, customers must return product no
Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
56952 units