Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 4
Summary
The FDA issued a Class I for Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN by Cardinal Health 200, LLC. Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist..
Details
Source
Device Recall
External ID
Z-1050-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
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/Code Info: 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 Affected: 4620 units
Reason for Recall
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Distribution
US and EMEA, Japan, Latin America
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-04
Company
Waukegan, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 140 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1050-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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