Z-1135-2019 Class II Terminated
FDA device recall Z-1135-2019 was initiated by Ethicon, Inc. on March 12, 2019 and is designated Class II. Reason for recall: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. The recall status is terminated (terminated July 17, 2020). Affected quantity: 550,681 eaches (WW) Total.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 12, 2019
- Termination Date
- July 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 550,681 eaches (WW) Total
Product Description
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
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 Pattern
Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
Code Information
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