CHS Custom Convenience Kit recall: Sterility Concern
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
Why was CHS Custom Convenience Kit recalled?
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(1)Lot Number:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021
- Product
- CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
- Recalling firm
- Custom Healthcare Systems, Inc.
- Quantity
- (1) 750 units (2) 200 units
- Distribution
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- Recall date
- October 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)