Port Access Kits incorrectly labeled as IV Start Kits
Medical Action Industries is recalling Port Access Kits that are incorrectly labeled as IV Start Kits on the individual kit label. The case label is correct; mislabeling could cause confusion about the product's identity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error with no reported illnesses or injuries. Per the rubric, minor labeling errors without reported harm are classified as Moderate (Score 2).
Plain-English summary
Medical Action Industries, Inc. is recalling Port Access Kits (Reference #76511B) due to incorrect labeling. The kits are incorrectly labeled as "IV Start Kits" on the individual kit label, although the case label correctly identifies them as Port Access Kits.
The error affects 24 cases containing 480 kits distributed to Minnesota. The affected products have the following lot information: Port Access Kit Lot 294281 (expires 9/28/2023, UDI #1080916018095) and Lot 294589 (expires 12/20/2024, UDI #20809160195991).
Customers who have received these products should check the individual kit label against the case label. Any kits where the label identifies them as "IV Start Kit" should not be used until verified. Contact Medical Action Industries, Inc. for instructions regarding return or replacement of the affected products.
The recalled product
- Product
- Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device
- Hazard
- mis-labeling
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 (5)
- Port Access Kit case label - Lot 294281
- exp. 9/28/2023
- UDI #1080916018095. IV Start Kit label - Lot 294589
- exp. 12/20/2024
- UDI #20809160195991.
Distribution
Distributed in 1 state:
- MN
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