Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.

FDA recall notice · announced February 12, 2014 · Insight Instruments

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Marketed without an Approved NDA/ANDA.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.
Quantity: 316,464 kits
Status: Terminated
Products in this recall event:
- Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393. (D-1056-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.