Recalls / —
—#105125
Product
The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.
- FDA product code
- FCK — Instrument, Biopsy, Suction
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G.
Why it was recalled
This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked EnCor (Trademark) packaging trays, plastic PETG tray the probe is packaged in was cracked.
Root cause (FDA determination)
Packaging
Action the firm took
The firm sent the customer notification letter on 11/07/11, via FedEx with proof of delivery notice. The letter notified customers of the reason for recall that units from the affected lot may have packaging damage resulting from transportation. The letter instructed customers to check all inventory locations , remove any identified product, to not use the affected product, and return the affected product to Bard Peripheral Vascular, Inc., 1415 W. 3rd Street, Tempe, Arizona 85281. The letter also instructed customers to fill out the recall and effectiveness check form and fax it to 1-800-894-6772. Customers were instructed to call 1-800-321-4254, Option #2 Ext 2727 for a return authorization number to facilitate the expedient return of the product. For questions regarding this recall call 480-894-9515
Recalling firm
- Firm
- Bard Peripheral Vascular Inc
- Address
- 1625 W 3rd St, Tempe, Arizona 85281-2438
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, LAPAC, and Australia
Timeline
- Recall initiated
- 2011-11-03
- Posted by FDA
- 2011-12-02
- Terminated
- 2012-03-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #105125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.