Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1273-2013Class II

Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens &...

Cypress Medical Products LLC / initiated 2013-04-15 / Terminated

Cypress Medical Products LLC began a recall of Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1273-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cypress Medical Products LLC
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.
Product code
HFW Clamp, Umbilical
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.
FDA 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 in commerce
150 Cases (75,000 Units)
Distribution
US Distribution to the state of VA only.
Product codes and lots
Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1273-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1273-2013Class IITerminatedVoluntary: Firm initiated