Sterile Custom Packs to be used in surgical procedures recall
Sterile Custom Packs to be used in surgical procedures.
Why was Sterile Custom Packs to be used in surgical procedures recalled?
The surgical gowns were manufactured in a facility that is not registered by the FDA.
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?
ACS Tray Numbers: AGD1401; Lot # 647191, Exp. Date 06/31/2020 (72 kits) and Lot # 685191 Exp. Date 03/31/2020 (6 kits) WPP147H; Lot # 684191, Exp. Date 11/12/2020 (20 kits) and Lot # 723191 Exp. Date 10/04/2020 (4 kits) SVOH38N; Lot # 654191, Exp. Date 12/12/2020 (32 kits)
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Recalling firm
- American Contract Systems
- Quantity
- 2868 kits total
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)