Recalls / —
—#144307
Product
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
- FDA product code
- OHG — Circumcision Tray
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- Affected lot / code info
- SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406
Why it was recalled
Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
Root cause (FDA determination)
Labeling Change Control
Action the firm took
Cardinal Health sent an URGENT: PRODUCT RECALL letter dated February 29, 2016, to affected consignees explaining the reason for the product recall and actions that should be taken by the end user. These included the following actions: 1. STOP using affected product. 2. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices. 3. NOTIFY any customers to whom you may have distributed product affected by this recall. 4. CONTACT the appropriate Customer Service group to arrange for return of any affected product you may have: " Hospital800.964.5227 " Distributor800.635.6021 The firm asks that consignees who have question or requests of special assistance relating to the recall should contact Cardinal Health Customer Advocacy at 800.292.9332. For questions regarding this recall call 847-473-1500.
Recalling firm
- Firm
- Cardinal Health
- Address
- 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726
Distribution
- Distribution pattern
- Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Timeline
- Recall initiated
- 2016-02-29
- Terminated
- 2018-03-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144307. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.