Recall Z-2639-2024— Microtek Medical Inc.

Name: FDA recall Z-2639-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-03

Class II · Ongoing

Class II FDA medical device recall by Microtek Medical Inc., initiated 2024-06-03. It names one FDA 510(k) clearance: K811233. Product: C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).. Reason: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film..

Recalling firm: Microtek Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-06-03
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K811233 — I.V. PLASTIC BAGMedi-Plast Intl., Inc.·cleared 1981-06-17

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

C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

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