C.A. Greiner HOLDEX Plastic Cannula Recalled for Sample Leakage
C.A. Greiner & Sohne is recalling 390,000 units of HOLDEX Plastic Cannulas (Lot A19073FK) because sample may leak from the sleeve covering the needle.
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 2/5 (Moderate).
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, and the defect involves a functional failure (leakage) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
C.A. Greiner & Sohne Gesellschaftmbh is recalling 390,000 units of HOLDEX Plastic Cannulas, Item # 450216, Lot # A19073FK. These devices are intended for routine specimen withdrawal from collection bags or bottles through needleless cannula ports.
The recall was initiated because sample may leak from the sleeve covering the needle inside the cannula. This defect could compromise the integrity of the specimen collection process.
The affected units were distributed nationwide in the United States, including in Utah and Tennessee. Users should stop using the affected cannulas and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
- Manufacturer
- C.A. Greiner & Sohne Gesellschaftmbh
- Hazard
- Affected units
- 390,000
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 (1)
- Lot # A19073FK
Distribution
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