Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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.