Reported Feb 28, 2024 · Ongoing
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE…
Cardinal Health 200, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
10 of 10 products
| # | Product as published |
|---|---|
| 1 | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG |
| 2 | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG |
| 3 | Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT |
| 4 | Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY |
| 5 | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG |
| 6 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE |
| 7 | Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 16FR (5.3 MM), 5CC |
| 8 | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person) |
| 9 | Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 18FR (6.0 MM), 5CC |
| 10 | Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE |
- Lot codes and dates
a) P4P16CSDKUDI/DI 20884521174068 (cs)10884521174061 (ea)
- Lot Numbers
213421826422312130642231213164223190116422319012642303822464230300706423071106642310808164231560946423191003642319213064220330096422102184642211031564221304556422144493642215824164221650046422179200642219400664230020206423044003642304400464230170336423030069642308700564230904126423122064642321324164232200686422116268642305206264232210276422067261642216805064231361506423136149642312908364230904126422011511642201201664220240146422006035642205315264220952426422137389642215117864b) P4P18CSDKUDI/DI 20884521174075 (cs)10884521174078(ea)
- Lot Numbers
22312135642308004464231910056422158243642232517864231220696421342185642203931664
- Amount recalled
- 195600 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
Stop using this product now
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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