Reported Jan 6, 2021 · Terminated
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot #…
ROi CPS LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
71 of 71 products
| Model / number | Product as published |
|---|---|
800221010 | Regard, PACEMAKER, , Lot # 82466. |
800109003 | Regard, BASIC, Lot # 83411. |
800070009 | Regard, MAJOR EAR, , Lot # 82442. |
800040011 | Regard, NEURO, , Lot # 82504. |
800003011 | Regard, LAP CHOLE, , Lot # 82497. |
800075010 | Regard, SHOULDER ARTHRO, , Lot # 82490. |
800058007 | Regard, CERVICAL, , Lot # 82592. |
800027008 | Regard, ARTHROSCOPY, , Lot # 82582. |
800013010 | Regard, MAJOR SURGERY, , Lot # 82844. |
800057012 | Regard, GENERAL SURGERY, , Lot # 82832. |
800024006 | Regard, SEPTO SINUS ENDO, , Lot # 82876. |
800019009 | Regard, MINOR FMOL-LADY OF THE LAKE, , Lot # 82893. |
800072009 | Regard, KNEE ARTHRO, , Lot # 83058. |
800096005 | Regard, LAP, , Lot # 83139. |
800121 | Regard, KNEE ARTHROSCOPY, , Lot # 83251. |
800093007 | Regard, CYSTOSCOPY, , Lot # 83138. |
800035007 | Regard, LAP CHOLE, , Lot # 83257. |
800007011 | Regard, PERIPHERAL VASCULAR, , Lot # 83106. |
800083006 | Regard, PACEMAKER, , Lot # 82886. |
800056005 | Regard, I&D, , Lot # 83135. |
- Lot codes and dates
- Lot Numbers
176 of 176 codes
824668341182442825048249782490825928258282844828328287682893830588313983251831388325783106828868313583050832648287983383832718358383421835608327383575835768284783598824728241782389824738242782501824968250782574824788246982485825848258882600825978259382594826068282882825828828303382880828878304883073
- Lot Numbers
- Amount recalled
- 17,700 total kits
Where it was sold
Why it was recalled
Gauze sponges contained in custom kits may be flaking or fraying.
This product could cause temporary or reversible health problems — stop using it.
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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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