U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: February 19, 2019
Create Date: April 04, 2019
Recall Status: Open, Classified
Recall Number: Z-1088-2019
Recall Event ID: 82248
510(K)Number: K081495
Product Classification: Knife, ophthalmic – Product Code HNN
Product: Micro Knife 5.0mm 30¿, Part Number 0001522
The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
Code Information: Lot Number 180615
Recalling Firm/Manufacturer: Beaver Visitec
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information Contact: Genci Omari
781-906-6925
Manufacturer Reason
The product contains a misprinted expiration date on the peel pack. Both were printed as “180615”, which is the lot number. The Lot number is correct.
FDA Determined Cause: Error in labeling
Action: The firm, Beaver-Visitec International, Inc, sent an “URGENT: MEDICAL DEVICE RECALL” notification letter dated 2/19/19 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
1. Immediately examine your inventory and quarantine product from this lot subject to recall. If you have further distributed this product, please identify your customers and notify them of this product recall. Consider all potential users of this product in your user supply chain.
2. Complete and return the enclosed Product Recall Notice Response & Return Form IMMEDIATELY, even if you do not have product to return via Fax 866-906-4304 or email a copy to [email protected]. Please include a copy of the completed Response & Return Form with your shipment in the address provided below.
3. Return All quarantined product from the affected lot to our company utilizing the Return Merchandise Authorization sticker label return (Figure 2) that is included in this letter. You may use the prepaid BVI Fed Ex number for your return. Return Merchandise–Beaver- Visitec International, Inc.
Attn: QIC Team- SF74660-0001522; 3550 Roy Orr Blvd. Ste. 180
Grand Prairie, TX 75050. Please use BVI FedEx account 122227600
when shipping the returns back to Grand Prairie.
If you have any specific product replacement questions you may contact our Customer Service Team at: [email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
Quantity in Commerce: 97 boxes (10units/box)
Distribution: US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK.
Total Product Life Cycle: TPLC Device Report
Original source can be found here.
