Recall Z-1134-2014
DeRoyal Industries Inc · initiated January 16, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Codes / lots: lot numbers 33347799, 33444071, and 33423747
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1134-2014
- Initiated
- January 16, 2014
- Posted by FDA
- March 4, 2014
- Terminated
- October 13, 2015
- Product code
- HFX – Clamp, Circumcision
- Quantity
- 2504 units
- Distribution
- US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
- Recalling firm
- DeRoyal Industries Inc, Powell, TN