Z-1273-2013 Class II Terminated
FDA device recall Z-1273-2013 was initiated by Cypress Medical Products LLC on April 15, 2013 and is designated Class II. 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 no… The recall status is terminated (terminated August 10, 2015). Affected quantity: 150 Cases (75,000 Units).
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- April 15, 2013
- Termination Date
- August 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 Cases (75,000 Units)
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.
Distribution Pattern
US Distribution to the state of VA only.
Code Information
Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.