Recall record at a glance
| Official record | Z-1805-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medtronic Perfusion Systems |
| Report date | May 22, 2024 |
| Recall initiation date | Mar 19, 2024 |
| Quantity | 17221 units |
| Location | Brooklyn Park, MN, United States |
Official product description
Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C
Why the product was recalled
Potential for unsealed sterile packing.
Distribution information
Worldwide distribution.
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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