| Class 1 Device Recall Cardinal Health COVIDIEN Dover | |
Date Initiated by Firm | December 04, 2023 |
Date Posted | February 16, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1045-2024 |
Recall Event ID |
93551 |
510(K)Number | K903340 |
Product Classification |
Tray, catheterization, sterile urethral, with or without catheter (kit) - Product Code FCM
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Product | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1200 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" URINE METER ADD-A-FOLEY TRAY, 400 ML, NEEDLE SAMPLING, DRAIN SPOUT, PREP TRAY; Dover" SILICONE ELASTOMER COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" 100% SILICONE FOLEY CATHETER KIT, 5 CC, 2-WAY, 16 FR (5.3 MM), LUBE, STRL WATER, 10CC SYRINGE; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE |
Code Information |
a) 8887600776, UDI/DI 30884521003389 (cs), 10884521003385 (ea), Lot Numbers: 2301032164, 2206016464, 2210904964, 2218622964, 2225305364, 2305232064, 2217924364.
REF 6256, Lot Number: 2209525764
REF 6175, Lot Numbers: 2205319864, 2205328564
REF 2018, Lot Numbers: 2205334664
REF 76020, Lot Numbers: 2209408564, 2210208264, 2211007864, 2211610264, 2215109464, 2222808464, 2220707664, 2220726364, 2223515264, 2224800564, 2307904064, 2315710664, 2316409064
REF 76000, Lot Numbers: 2209408264, 2210207964, 2211007564, 2213709364, 2214416164, 2211609964, 2215109364, 2216525364, 2215809864, 2217211464, 2217912564, 2220901064, 2303825364, 2304507464, 2305228764, 2305228964, 2305706764, 2312920964, 2321910264, 2308203564, 2313507264, 2314219064
REF 5027, Lot Numbers:2214434964, 2214435064, 2225305264, 2227031164, 2301018164, 2305904064, 2319902764
b) 8887600784, UDI/DI 30884521003396 (cs), 10884521003392 (ea), Lot Numbers: 2215120764, 2215827464.
REF 3044, Lot Number: 2208815964.
REF 2101, Lot Numbers: 2214422964, 2214423064
REF 5029, Lot Numbers: 2204637764, 2208812764, 2208812864, 2217922164
REF 2006, Lot Numbers: 2215118264
REF 2016, Lot Numbers: 2205334564, 2215118364
c) 8887601220, Lot Numbers: 2208901164, 2216807564
REF 76030, Lot Numbers: 2134208364, 2208109364, 2215109564, 2209408664, 2210208364
REF 76010, Lot Numbers: 2132716964, 2132717064, 2133422864, 2133422964, 2134110464, 2134110564, 2208109064, 2211007664, 2211610064, 2212328664, 209408364, 2210208064
REF 76012, Lot Numbers: 2132134964, 2208109164, 2211007764, 2210208164, 2209408464
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Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC 3651 Birchwood Dr Waukegan IL 60085-8337
|
For Additional Information Contact | 847-887-5500 |
Manufacturer Reason for Recall | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
FDA Determined Cause 2 | 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 GMB-FieldCorrectiveAction@cardinalhealth.com 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:
GMB-FieldCorrectiveAction@cardinalhealth.com 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.
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Quantity in Commerce | 17640 units |
Distribution | US and EMEA, Japan, Latin America |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = FCM
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