Recall record at a glance
| Official record | Z-1933-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medline Industries Inc. |
| Report date | Jun 6, 2018 |
| Recall initiation date | Apr 24, 2018 |
| Quantity | 220608 units |
| Location | Northfield, IL, United States |
Official product description
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
Why the product was recalled
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Distribution information
Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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