Recall Z-1273-2013 ยท HFW Clamp, Umbilical
Cypress Medical Products LLC
Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
| Date | May 8, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| Reason | Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended. |
| Root cause | Unknown/Undetermined by firm |
| Action | Cypress Medical Products sent an "Urgent Voluntary Medical Device Recall" notification and an associated response form dated April 15, 2013 to their only customer for this device - Owens & Minor. The product problem was identified and recommended actions provided. |
| Quantity | 150 Cases (75,000 Units) |
| Distribution | US Distribution to the state of VA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.