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Recall Observatory FDA recall evidence

Device product

Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE

Z-0237-2019

September 20, 2018

Class II

Product summary

Firm
Micro-Tech (Nanjing) Co., Ltd.
Event
Event 81176
Status
Terminated
Classification
Class II
Quantity
1360 pcs
Official record key
device-enforcement:Z-0237-2019

Official wording

Reason: Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units

Code information: Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408

Distribution pattern: US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units