DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Reported: March 12, 2014 Initiated: January 16, 2014 #Z-1134-2014
Product Description
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Reason for Recall
Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 2504 units
- Distribution
- US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.. Recalled by DeRoyal Industries Inc. Units affected: 2504 units.
Why was this product recalled? ▼
Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2014. Severity: Moderate. Recall number: Z-1134-2014.
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