Recall record at a glance
| Official record | Z-2330-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Cardinal Health 200, LLC |
| Report date | Jul 17, 2024 |
| Recall initiation date | May 29, 2024 |
| Quantity | 13487 units |
| Location | Waukegan, IL, United States |
Official product description
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA
Why the product was recalled
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Distribution information
Nationwide
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
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