FDA Device Recall Z-1050-2024

Cardinal Health 200, LLC · Waukegan, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2-WAY; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 16 FR (5.3 MM); Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 18 FR (6.0 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER-LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAG

Lot / serial / GTIN: a) 6146LL, UDI/DI 30884521015504 (cs), 10884521015500 (ea), Lot Numbers: 2222830564, 2234606164, 2300129064, 2300129264, 2206723564, 2206723664, 2213047764, 2213741964, 2214452664, 2216503164, 2211628464, 2225100964, 2305403264, 2207404564, 2203933464, 2209525664, 2210210364, 2210210464, 2212323064, 2215116164 b) P4P16CSD, UDI/DI 20884521143347 (cs), 10884521143340 (ea), Lot Numbers: 2231220064, 2303011264, 2309041164, 2312914064, 2319901964, 2310300564, 2322102864, 2207803464, 2212321564 c) 7006ICLL, Lot Numbers: 2215120464, 2223120264 d) 7006LL, Lot Numbers: 2207805664, 2208817564, 2212323864, 2215826764, 2223542964, 2223543064, 2231912364, 2232102364, 2206721364, 2206721464, 2210904064, 2209525964, 2213048664, 2232601264

Quantity: 4620 units

Reason for recall

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Recall record

Recall number: Z-1050-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US and EMEA, Japan, Latin America
Recall initiated: 2023-12-04
Classified by FDA Center: 2024-02-16
FDA published: 2024-02-28
Recalling firm: Cardinal Health 200, LLC
Firm location: Waukegan, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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