Recall Z-1331-2019— Shippert Medical Technologies

Name: FDA recall Z-1331-2019
Creator: U.S. Food and Drug Administration
Published: 2018-02-02

Class II · Completed

Class II FDA medical device recall by Shippert Medical Technologies, initiated 2018-02-02. It names one FDA 510(k) clearance: K092482. Product: Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.. Reason: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch..

Recalling firm: Shippert Medical Technologies
Classification: Class II
Status: Completed
Initiated: 2018-02-02
Firm location: Centennial, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K092482 — TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500Shippert Medical Technologies Corp.·cleared 2009-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

Reason for recall

The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.