Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens &...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1273-2013 | Class II | Terminated | Voluntary: Firm initiated |
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