Single Shot Epidural Tray Catalog Number: 8417
Reported: June 8, 2022 Initiated: February 22, 2022 #Z-1159-2022
Product Description
Single Shot Epidural Tray Catalog Number: 8417
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
- Recalling Firm
- Busse Hospital Disposables, Inc.
- Units Affected
- 400 units
- Distribution
- Nationwide
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
Single Shot Epidural Tray Catalog Number: 8417. Recalled by Busse Hospital Disposables, Inc.. Units affected: 400 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-1159-2022.
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