Z-1079-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- October 23, 2017
- Termination Date
- June 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
SUTURE REMOVAL TRAY, SET or KIT
Reason for Recall
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Distribution Pattern
Nationally
Code Information
55160 55395 55525 60125 60255 60360 60365 75435 84105 86125 SR530 Lot codes: 2016011801 2016011290 2016022390 2016042990 2016061390 2016080390 2016101790 2017011090 2015111990 2017022790 2015062201 2015081001 2016032101 2016050901 2016091201 2017032001 2017061501 2015042701 2015100501 2015120701 2016011101 2016071101 2016103101 2017011601 2017071201 2015100501 2016012501 2016071101 2016090501 2017013101 2017021601 2017051101 2017080701 2016060601 2017071101 2015111601 2016030701 2016101001 2015062201 2015110201 2016022201 2016091201 2015050401 2015082401 2016010401 2016072501 2017042401 2016101001 2017021301 2017071101 2016050201 2016111401 2015062901 2015081701 2015090701 2015110201 2016021501 2016040401 2016071101 2016102401 2016121401 2017021301 2017041901 2017070501 2017071801 2015072001 2016111401 2016021501 2016062001 2016081501 2016062701 2016040790 2015102990 2015120790 2016011890 2016050990 2016072590 2016091990 2017010390 2017012390 2017052290 2017062290 2015061501 2015081001 2015102601 2015122801 2016030701 2016050901 2016072501 2016101001 2016122701 2017041201 2017071001 2015060801 2015072001 2015082401 2015102601 2015122801 2016022201 2016050201 2016072501 2016091201 2016110701 2017022801 2017053101 2017060501 2016122001 2017041101