Custom Procedure Kit recall: Sterility Concern
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The…
Why was Custom Procedure Kit recalled?
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
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?
(01)00884450515105 Lot # T1907711,
- Product
- Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 80 kits
- Distribution
- US distribution to: KY, RI, and MD
- Recall date
- January 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)