Bag Decanter II Medical Device Recalled for Sterile Packaging Defects
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a sterile barrier defect that poses a risk of contamination. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury scores at most 3 (High).
Plain-English summary
Microtek Medical Inc. is recalling Bag Decanter II (REF 2002S) medical devices due to defects in the sterile packaging material. During sterile barrier testing, samples were found to have pinholes and tears in the poly/Tyvek packaging film. A compromised sterile barrier could allow contamination to enter the product, potentially affecting device performance and safety.
The recalled devices were distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong. The recall affects approximately 135,999 cases containing 6,799,950 units. Consumers, healthcare facilities, and distributors who have received these products should stop using them and contact Microtek Medical Inc. for instructions on returns or replacements.
The recalled product
- Product
- Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Manufacturer
- Microtek Medical Inc.
- Category
- Medical Device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- SKU/UDI-Device Identifier: 2002S/00748426002399
- Lot Numbers: 200403
- 211013
- 210626
- 200409
- 190913
- 200420
- 200422
- 190510
- 190319
- 200108
- 190415
- 190702
- 190109
- 190827
- 191022
- 200313
- 200306
- 200312
- 191212
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Microtek Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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