Z-1134-2019 Class II Terminated
FDA device recall Z-1134-2019 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 Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO
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 SUTURE 18"(45CM) 0 VIO D6043 MKM683, ML5314 VICRYL SUTURE 18"(45CM) 2-0 UND D6226 MJM912 VICRYL SUTURE 18"(45CM) 0 VIO J701D MJ6796 VICRYL SUTURE 18"(45CM) 3-0 VIO J713D MGK411 VICRYL SUTURE 18"(45CM) 4-0 UND J714D ME5059 MKM907 VICRYL SUTURE 18"(45CM) 2-0 VIO J726D ME5454 VICRYL SUTURE 18"(45CM) 0 VIO J727D MHZ777 VICRYL SUTURE 18"(45CM) 2-0 VIO J739D MGZ324 MHM399 VICRYL CT VIO 8X18IN 0 S/A CT-1 CR 740D ME6539 MJM523 VICRYL SUTURE 18"(45CM) 1 VIO J741D MGZ624 MJ5193 VCL CT UD 8X18IN 2-0 S/A CP-2 CR J762D MJZ094 MLZ026 VCL CT VIO 8X18IN 3-0 S/A SH-1 CR J772D MHZ196 VICRYL CT VIO 8X18IN 2-0 S/A SH CR J775D MLZ864 VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR J839D MG2349 MG2593 MG2666 MG7585 MK2820 VICRYL CT UD 8X18IN 0 S/A CT-1 CR J840D MEK770 MGK812 MJK773 MM6633 VCL CT UD 8X18IN 1 S/A CT-1 CR J841D MEK194 MGK749 MMM998 VCL CT UD 8X18IN 3-0 S/A SH CR J864D MEK524 MGZ556 MHZ379 MHZ475 MJK262 VICRYL SUTURE 18"(45CM) 0 UND JB840 MEK959 MGM275 MGM643 MM6544 VICRYL CT VIO 8X27IN 0 S/A CT-1 CR JJ31G MJK828 VICRYL SUTURE 27"(70CM) 1 UND JJ40G ME6809 VICRYL CT UD 8X27IN 0 S/A CT-1 CR JJ41G ME5281 MGZ466 MGZ563 MHK212 VICRYL SUTURE 27"(70CM) 0 VIO JJ81G MKK878