Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
Reported: January 11, 2017 Initiated: December 15, 2016 #D-0242-2017
Product Description
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Gentell, Inc
- Units Affected
- 3,000 gauzes
- Distribution
- United States
- Location
- Bristol, PA
Frequently Asked Questions
What product was recalled? ▼
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007. Recalled by Gentell, Inc. Units affected: 3,000 gauzes.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 11, 2017. Severity: Moderate. Recall number: D-0242-2017.
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