Medtronic PAK Needle Beveled and Trocar Tips Recalled for Packaging Error
Medtronic is recalling 36 units of PAK Needle Beveled and Trocar Tips because packaging may contain incorrect needle types instead of the required combination.
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. The hazard is a packaging/labeling error regarding the contents of the sterile package, which is a moderate risk of using the wrong device type, but no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 36 units of PAK Needle Beveled and Trocar Tips, Reference 8670009. The recall is due to a packaging error where the product may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of the required one diamond-tipped needle and one bevel-tipped needle.
The affected units are from Lot number 0521148W with an expiration date of 10/21/2021. These sterile, prescription-only devices were distributed in the United States to the state of Oklahoma and internationally to Italy, Germany, France, Belgium, Spain, and Japan.
Healthcare providers and patients should check their inventory for this specific lot number and reference. If the packaging contains the incorrect needle configuration, the product should not be used. Medtronic is the recalling firm responsible for this action.
The recalled product
- Product
- Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 36
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 (2)
- Lot number 0521148W
- Exp. 10/21/2021
Distribution
Distributed in 1 state:
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