TZ Medical Neptune Plus Hemostasis Pad Recall for Labeling Mismatch
TZ Medical Inc. is recalling Neptune Plus hemostasis pads because the instructions for use do not match the original FDA submission.
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: The recall is classified as FDA Class II due to a labeling error (IFU mismatch) which is a minor documentation issue unlikely to cause serious harm, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
TZ Medical Inc. is recalling 32,170 units of Neptune Plus Hemostasis Pads with Antimicrobial Barrier, Part number 8870-03. The recall is due to a discrepancy where the instructions for use (IFU) of the pads do not match the documentation submitted in the original 510k application. Specifically, the phrase "for haemostasis following needle/sheath removal" needs to be removed from the IFU.
The affected products were distributed nationwide in the United States. The recall involves specific lot numbers: AGR554, AGR554\20, AGR554\24, AGR554/24, AGR570\28, AGR570/43, AGR744124, and AGR744137.
This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences. Healthcare providers and consumers should stop using the affected lots and contact TZ Medical Inc. for further instructions or replacement.
The recalled product
- Product
- Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- Manufacturer
- TZ Medical Inc.
- Category
- Medical Device — Hemostasis Pads
- Hazard
- Affected units
- 32,170
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 (8)
- Lot Numbers: AGR554
- AGR554\20
- AGR554\24
- AGR554/24
- AGR570\28
- AGR570/43
- AGR744124
- AGR744137.
Distribution
Distributed nationwide across the United States.
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