CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight Instruments, Inc., 25
FDA device recall Z-2220-2010 · posted 2010-08-13 · Terminated
Recall details
- Recalling firm
- Insight Instruments, Inc.
- 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.
- Action taken
- All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KYG
- Quantity affected
- 16,128
- Distribution
- Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
- Date initiated
- 2010-05-12
- Date posted
- 2010-08-13
- Date terminated
- 2012-02-16
- Location
- Stuart, FL
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