Class II Recall

Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr.

Summary

The FDA issued a Class II for Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannu by Medtronic Perfusion Systems. Reason: Potential for unsealed sterile packing..

Details

Source

Device Recall

External ID

Z-1805-2024

Action Date

2024-05-22

Status

Ongoing

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

Lot/Code Info: a) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436; b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008; c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040; c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388; c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011; d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131; e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431; f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423; f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074; f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423; g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; h) Model Number 67516, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; i) Model Number 66118, GTIN 00613994878526, Lot Numbers: 2023041014; i) Model Number 66118, GTIN 20613994878520, Lot Numbers: 2023041014, 2023041015; j) Model Number 67318, GTIN 00613994879295, Lot Numbers: 2023040077; j) Model Number 67318, GTIN 00673978184241, Lot Numbers: 2023040077, 2023041391; j) Model Number 67318, GTIN 20613994879299, Lot Numbers: 2023040077, 2023041391, 202305C256; k) Model Number 67320, GTIN 00613994879288, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 00673978184258, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 20613994879282, Lot Numbers: 2023031377, 202307C051; l) Model Number 69320, GTIN 00613994879233, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 00673978184609, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 20613994879237, Lots Numbers: 2023041422, 2023041438, 202306C014, 202306C015; m) Model Number 67520, GTIN 00613994878359, Lot Numbers: 2023040082; m) Model Number 67520, GTIN 20613994878353, Lot Numbers: 2023040082; n) Model Number 66122, GTIN 20613994878544, Lot Numbers: 2023041016; o) Model Number 67522, GTIN 00613994878366, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 00673978184326, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 20613994878360, Lot Numbers: 2023040083, 2023040565, 202307C050; p) Model Number 67524, GTIN 00673978184333, Lot Numbers: 2023040084; p) Model Number 67524, GTIN 20613994878377, Lot Numbers: 2023040084, 2023040566, 202305C257; q) Model Number 67526, GTIN 00673978165585, Lot Numbers: 2023040569; q) Model Number 67526, GTIN 20613994878384, Lot Numbers: 2023040569, 202308C082; r) Model Number 66128, GTIN 00613994878571, Lot Numbers: 2023041020; r) Model Number 66128, GTIN 20613994878575, Lot Numbers: 2023041020, 202305C177; s) Model Number 39628, GTIN t) Model Number 67528, GTIN 20613994878391, Lot Numbers: 2023041036; u) Model Number 66130, GTIN 00613994878588, Lot Numbers: 2023040555, 202305C217; u) Model Number 66130, GTIN 20613994878582, Lot Numbers: 2023040555, 2023041414, 202305C217, 202305C218; v) Model Number 69331, GTIN 20613994879183, Lot Numbers: 2023041444, 202307C012; w) Model Number 66132, GTIN 00613994878601, Lot Numbers: 2023041428; w) Model Number 66132, GTIN 20613994878605, Lot Numbers: 2023041412, 2023041428, 202305C227; x) Model Number 67534, GTIN 20613994878421, Lot Numbers: 2023031249, 202308C079; y) Model Number 66236, GTIN 20613994878643, Lot Numbers: 2023041398, 202305C222; z) Model Number 91228, GTIN 20643169463015, Lot Numbers: 2023041070; aa) Model Number 91229C, GTIN 20643169463060, Lot Numbers: 2023041071; bb) Model Number 91263, GTIN 00673978187761, Lot Numbers: 2023041095; bb) Model Number 91263, GTIN 20613994887454, Lot Numbers: 2023041095, 202306C105; cc) Model Number 91240C, GTIN 00613994887306, Lot Numbers: 2023041082, 2023041083, 2023041084; cc) Model Number 91240C, GTIN 20613994887300, Lot Numbers: 2023041079, 2023041081, 2023041082, 2023041083, 2023041084, 2023041087, 2023041088, 202306C074, 202306C075, 202306C076, 202306C077; dd) Model Number 91263C, GTIN 20613994887447, Lot Numbers: 2023040116, 2023041097, 202306C103; ee) Model Number 91246, GTIN 00613994887535, Lot Numbers: 2023041089; ee) Model Number 91246, GTIN 20613994887539, Lot Numbers: 2023041089, 202306C101; ff) Model Number 91246C, GTIN 00613994887528, Lot Numbers: 2023041090; ff) Model Number 91246C, GTIN 20613994887522, Lot Numbers: 2023041090, 202306C123; gg) Model Number 91236C, GTIN 00613994887344, Lot Numbers: 2023041072; gg) Model Number 91236C, GTIN 20613994887348, Lot Numbers: 2023041072, 202306C065; hh) Model Number 91251, GTIN 00613994887498, Lot Numbers: 2023041092, 2023041094; hh) Model Number 91251, GTIN 20613994887492, Lot Numbers: 2023041092, 2023041094; ii) Model Number 91251C, GTIN 00613994887481, Lot Numbers: 2023040618, 202306C102; ii) Model Number 91251C, GTIN 20613994887485, Lot Numbers: 2023040617, 2023040618, 202306C102; jj) Model Number 93438, GTIN 00673978188201, Lot Numbers: 2023040626; jj) Model Number 93438, GTIN 20613994887034, Lot Numbers: 2023040626; kk) Model Number 93448C, GTIN 20613994887256, Lot Numbers: 2023040627

Quantity Affected: 17221 units

Reason for Recall

Potential for unsealed sterile packing.

Distribution

Worldwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-03-19

Company

Medtronic Perfusion Systems

Brooklyn Park, MN

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Perfusion Systems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medtronic Perfusion Systems have FDA actions?

Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1805-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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