Recall Z-1134-2014— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2014-01-16, terminated 2015-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.. Reason: Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-16
- Terminated
- 2015-10-13
- Firm location
- Powell, TN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.