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Terminated

CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.

FDA Recall Z-0264-04 · Posted 2003-12-24

Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHJM
Date Initiated2003-11-10
Date Terminated2004-04-05
Product Quantity2500 packs

Reason for Recall

The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.

Firm Action

The recalling firm issued a recall notification dated 11/13/03 to their direct accounts. The recall notification explains the problem and return the product.

Root Cause

Other

Distribution Pattern

The product was shipped to hospitals/medical facilities and physicians in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NH, NY, NC, OH, PA, TN, TX, UT, VA, WA, WI, and WV. Nationwide. The product was also shipped to Puerto Rico, Argentina, Australia, Brazil, Canada, China, Hong, Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, The Netherlands, Philippines, Singapore, Spain, Taiwan, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940393PEREGRINE WIDE ANGLE LIGHT PIPEPeregrine Surgical , Ltd. · 1994-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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