Z-2399-2010
Peregrine 20 GA Endo Ocular Adjustable Laser Probe
Peregrine Surgical, LLC. / initiated 2010-07-19 / Terminated
Peregrine Surgical Ltd began a recall of Peregrine 20 GA Endo Ocular Adjustable Laser Probe on . The reason FDA records is "Product did not have proper 510(k) clearance". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2399-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Peregrine Surgical, LLC.
- Product
- Peregrine 20 GA Endo Ocular Adjustable Laser Probe
- Product code
- HQF Laser, Ophthalmic
- Reason for recall
- Product did not have proper 510(k) clearance
- FDA root cause
- Other
- Action
- A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm.
- Quantity in commerce
- 132 boxes
- Distribution
- Product was distributed to hospitals and eye surgery centers in Florida, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, Texas.
- Product codes and lots
- Device numbers: PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52. Lot numbers 926287, 937391, 931335, 933355, 935370, 937390, 940422, 916188, 917184, 919211, 920228, 922244, 925269, 916189, 917185, 919216, 920229, 923245, 925272, 952026, 002048, 005069, 916186, 918196, 919205, 920240, 924268, 926285, 916184, 918203, 919208, and 922239.
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