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U.S. Department of Health and Human Services

Class 2 Device Recall Peregrine 20 GA Endo Ocular Adjustable Laser Probe (Smart Flex)

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  Class 2 Device Recall Peregrine 20 GA Endo Ocular Adjustable Laser Probe (Smart Flex) see related information
Date Initiated by Firm July 19, 2010
Date Posted September 11, 2010
Recall Status1 Terminated 3 on September 30, 2010
Recall Number Z-2399-2010
Recall Event ID 56271
Product Classification Ophthalmic Laser - Product Code HQF
Product Peregrine 20 GA Endo Ocular Adjustable Laser Probe
Code Information 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.
Recalling Firm/
Manufacturer		 Peregrine Surgical Ltd
51 Britain Dr
New Britain PA 18901-5186
For Additional Information Contact Jayne Guthrie
215-348-0456
Manufacturer Reason
for Recall		 Product did not have proper 510(k) clearance
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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