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Terminated

CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. REF 60010.000, QTY 14 - This package contains 14 individual packs, each containing 1 sterile, single use ocular irrigation device. For external use only! Used as an ocular irrigation device.

FDA Recall Z-2220-2010 · Posted 2010-08-13

Recalling FirmInsight Instruments, Inc.
Recall StatusTerminated
Product CodeKYG
Date Initiated2010-05-12
Date Terminated2012-02-16
Product Quantity16,128

Reason for Recall

Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Products affected are Item Numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of BIOM Pack.

Firm Action

All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.

Official Source

View FDA Recall →

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

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