Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
- Recall Initiated
- November 17, 2022
- Posted
- February 6, 2023
- Recall Number
- Z-1089-2023
- Quantity
- 194 cases (508 units)
- Firm Location
- Northfield, IL
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Info
a. GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/GTIN: 10193489205527, Lot Number: 22JDA531,22IDB178,22IDA705; b. OB GYN LAP PACK-LF, Item Number: DYNJ43413C, Case UDI/GTIN: 40193489901185, Unit UDI/GTIN: 10193489901184, Lot Number: 22JBS296; c. VAGINAL HYSTERECTOMY PACK, Item Number: DYNJ47624B, Case UDI/GTIN: 40193489735360, Unit UDI/GTIN: 10193489735369, Lot Number: 22KBB429,22IBE503; d. DELTA PACK, Item Number: DYNJ59117A, Case UDI/GTIN: 40193489457897, Unit UDI/GTIN: 10193489457896, Lot Number: 22JMC869,22JMC852,22HMD762; e. MAJOR VAGINAL-LF, Item Number: DYNJ901807G, Case UDI/GTIN: 40193489814157, Unit UDI/GTIN: 10193489814156, Lot Number: 22IDC043; f. GYN LAPAROSCOPY II, Item Number: DYNJS2030D, Case UDI/GTIN: 40193489214148, Unit UDI/GTIN: 10193489214147, Lot Number: 22JDA984;
Root Cause
Device Design
Action Taken
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.