510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1050-2024Class I

Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100%...

Medtronic, Inc. / initiated 2023-12-04 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Cardinal Health 200, LLC began a recall of 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... on . FDA classified it as Class I and gives the reason as "Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1050-2024
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic, Inc.
Product
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
Product code
EZL Catheter, Retention Type, Balloon
Reason for recall
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
Cardinal Health Issued an URGENT KIT/TRAY COMPONENT RECALL NOTICE ON 12/04/2023 via FedEx next day delivery. The notice explained the issue, potential risk to health, and requested the following actions be taken: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits/trays. 2. ALERT your clinicians of this action. 3. AFFIX the enclosed WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. NOTE if you have transferred the affected kits/trays to other departments or facilities within your system, please provide a copy of this notice and recall acknowledgement form to them. 5. DISTRIBUTOR if you have further distributed affected kits/trays, please notify your customers of this recall. 6. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of over labeled product via email [email protected] or fax to 614.652.9648. Additional labels will be sent to your facility upon request. For field action concerns, please contact the field action team at: [email protected] or call 800-292-9332. On 12/21/2023, Cardinal Health issued an URGENT: EXPANSION KIT/TRAY COMPONENT RECALL notice stating the following: As an update to Cardinal Healths initial communication on December 05, 2023, additional kit/trays are being included as part of the component recall. If you did not receive the initial communication on December 05, 2023, you were not impacted by the initial scope of the event. Instructions below are unchanged. Please reference Attachment 1 - Updated Impacted Products V2 for additional products impacted. The notice explained the issue, potential risk to health, and requested the same actions be taken as listed above in the 12/04/2023 letter.
Quantity in commerce
4620 units
Distribution
US and EMEA, Japan, Latin America
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1050-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1043-2024Class IOngoingVoluntary: Firm initiated
Z-1044-2024Class IOngoingVoluntary: Firm initiated
Z-1045-2024Class IOngoingVoluntary: Firm initiated
Z-1046-2024Class IOngoingVoluntary: Firm initiated
Z-1047-2024Class IOngoingVoluntary: Firm initiated
Z-1048-2024Class IOngoingVoluntary: Firm initiated
Z-1049-2024Class IOngoingVoluntary: Firm initiated
Z-1050-2024Class IOngoingVoluntary: Firm initiated
Z-1051-2024Class IOngoingVoluntary: Firm initiated
Z-1052-2024Class IOngoingVoluntary: Firm initiated