Z-1136-2019 Class II Terminated
FDA device recall Z-1136-2019 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
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
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
Lot Code: MGM110