VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VICRYL PLUS SUTURE 18"(45CM) 1 UND VICRYL PLUS SUTURE 27"(70CM) 0 UND VICRYL PLUS SUTURE 27"(70CM) 2-0 UND - Product Usage: Coated VICRYL Suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues
This recall has been terminated (originally issued March 12, 2019).
- Company
- Ethicon, Inc. Us
- Recall Initiated
- March 12, 2019
- Terminated
- July 17, 2020
- Recall Number
- Z-1135-2019
- Quantity
- 550,681 eaches (WW) Total
- Firm Location
- Somerville, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Distribution
Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
Lot / Code Info
Product Name/Product Code/Lot Numbers: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VCP713D MJ6586 VICRYL PLUS SUTURE 18"(45CM) 4-0 UND VCP714D MJZ386 VICRYL PLUS SUTURE 18"(45CM) 0 UND VCP724D MJM852 VICRYL PLUS SUTURE 18"(45CM) 0 VIO VCP727D MH2267 VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VCP738D MJ7656 VICRYL PLUS SUTURE 18"(45CM) 0 VIO VCP740D MH2821 VICRYL PLUS SUTURE 18"(45CM) 1 VIO VCP753D MGM113 VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VCP762D MGK480 MK5042 MKK981 VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VCP773D MGZ815 VICRYL PLUS SUTURE 18"(45CM) 2-0 VIO VCP775D ML2512 VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO VCP784D MJM663 VICRYL PLUS SUTURE 27"(70CM) 2-0 VIO VCP785D MK6998 VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VCP839D ME2930 MK2929 ML7047 VICRYL PLUS SUTURE 18"(45CM) 1 UND VCP841D MG2339 VICRYL PLUS SUTURE 18"(45CM) 3-0 UND VCP864D MK2923 VICRYL PLUS SUTURE 27"(70CM) 0 UND VCPP41D MK6415 ML5418 VICRYL PLUS SUTURE 27"(70CM) 2-0 UND VCPP42D MG6757
Root Cause
Packaging process control
Action Taken
Ethicon notified primary and secondary US consignees via UPS second day between March 12-15,2019. Receipt of the letter confirmed via UPS tracking. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, Middle East. Latin America and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter describes the problem and action to take:Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). Remove the product subject to this voluntary recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. Do not open foil pouches to confirm contents. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. Customers are required to return unused impacted VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products subject to this recall (removal) that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall (removal) by July 31, 2019. Questions regarding this recall (removal) or to report any customer complaints,contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266), Monday through Friday, 7:30 AM to 6:30 PM ET. A Business Reply Form (BRF) asked to be completed and returned.