Recall Z-0162-2018
Medline Industries Inc · initiated October 23, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Codes / lots: Model No. MSG1285, Lot No. 701893369485
Reason for recall
Possible open seal on top portion of the package. Could cause breach of sterility.
FDA-determined cause: Packaging
Action taken
Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.
Details
- Recall number
- Z-0162-2018
- Initiated
- October 23, 2017
- Posted by FDA
- November 21, 2017
- Terminated
- April 6, 2021
- Product code
- KGO – Surgeon'S Gloves
- Quantity
- 8,000 units
- Distribution
- Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
- Recalling firm
- Medline Industries Inc, Northfield, IL