ROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges
ROi CPS LLC is recalling 17,700 custom procedure packs because the gauze sponges inside may be flaking or fraying.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect (flaking/fraying) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ROi CPS LLC is recalling 17,700 custom procedure packs that contain banded 4x4 Raytec 16ply gauze sponges. The recall was initiated because the gauze sponges contained in these kits may be flaking or fraying.
The affected products are distributed in Missouri, North Carolina, Louisiana, and Florida. The recall covers numerous specific item numbers and lot numbers, including Regard PACEMAKER, BASIC, MAJOR EAR, NEURO, and various other surgical procedure packs.
Healthcare facilities and consumers should stop using these specific procedure packs and contact ROi CPS LLC for further instructions or a return.
The recalled product
- Product
- Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504.…
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Packs
- Affected units
- 17,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 82466
- 83411
- 82442
- 82504
- 82497
- 82490
- 82592
- 82582
- 82844
- 82832
- 82876
- 82893
- 83058
- 83139
- 83251
- 83138
- 83257
- 83106
- 82886
- 83135
Distribution
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