DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industr
FDA device recall Z-1134-2014 · posted 2014-03-04 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- 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.
- Action taken
- DeRoyal initiated the recall by sending overnight letters to its direct accounts on 01/16/2014. If distributors inform DeRoyal of further distribution, DeRoyal will contact those consignees in the same manner. If necessary, further communications will be sent in the form of another mailing, phone calls, and emails to materials management personnel when possible.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HFX
- Quantity affected
- 2504 units
- Distribution
- US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
- Date initiated
- 2014-01-16
- Date posted
- 2014-03-04
- Date terminated
- 2015-10-13
- Location
- Powell, TN
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