Recall Z-1273-2013— Cypress Medical Products LLC
Class II · Terminated
Class II FDA medical device recall by Cypress Medical Products LLC, initiated 2013-04-15, terminated 2015-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Cypress Medical Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-15
- Terminated
- 2015-08-10
- Firm location
- Mchenry, IL, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.