PlainRecalls
FDA Devices Moderate Class II Terminated

Single Shot Epidural Tray Catalog Number: 6797R2

Reported: June 8, 2022 Initiated: February 22, 2022 #Z-1172-2022

Product Description

Single Shot Epidural Tray Catalog Number: 6797R2

Reason for Recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Details

Units Affected
40 units
Distribution
Nationwide
Location
Hauppauge, NY

Frequently Asked Questions

What product was recalled?
Single Shot Epidural Tray Catalog Number: 6797R2. Recalled by Busse Hospital Disposables, Inc.. Units affected: 40 units.
Why was this product recalled?
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1172-2022.