Z-1088-2019Class III

Micro Knife 5.0mm 30, Part Number 0001522 The Beaver Micro Knife 5.0mm 30 is a sharp pointed tip intended for...

Name: Z-1088-2019 Micro Knife 5.0mm 30, Part Number 0001522 The Beaver Micro Knife 5.0mm 30 is a sharp pointed tip intended for...
Creator: Beaver Visitec
Published: 2019-02-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-02-19 / Terminated / root cause: labeling and UDI

FDA source

Beaver Visitec began a recall of 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... on 2019-02-19. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1088-2019
Classification: Class III
Status: Terminated
Initiated: 2019-02-19
Posted: 2019-04-04
Terminated: 2020-07-21
Recalling firm: Becton Dickinson & Co
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. .
Product code: HNN Knife, Ophthalmic
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Lot Number 180615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1088-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1088-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-04

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)