ROi CPS LLC recalls GS0008 2Y - Burn Pack - STL, Item Number 880082025
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
Read the official notice →- Date
- 2023-10-11
- Country
- United States
- Brand
- ROi CPS
- Product
- GS0008 2Y - Burn Pack - STL, Item Number 880082025
- Classification
- Class II
- Units
- Missouri
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More ROi CPS recalls
- 2024-01-24
US
ROi CPS LLC recalls regard Operative LAP, Item Number 800943001; surgical convenience kit
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- 2024-01-10
US
ROi CPS LLC recalls Regard Dressing change kit, Item Number 800026006
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
- 2023-11-22
US
ROi CPS LLC recalls Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of…
- 2023-05-03
US
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
FDA · DeviceROi CPS LLCUS Nationwide distribution in the states of FL and MO. There was no…Official notice →- 2022-11-30
US
ROi CPS LLC recalls regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
- 2022-07-27
US
ROi CPS LLC recalls Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
FDA · DeviceROi CPS LLCDistribution was made to MO. There was no foreign/military/government…Official notice →
Other drugs & medical recalls in the United States
- 2023-10-11
US
Siemens Medical Solutions USA, Inc recalls (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica…
In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential…
US
Philips Healthcare recalls Incisive CT, software version 5.0
Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted…
US
DKK Dai-Ichi Shomei Co., Ltd. recalls LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4…
The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause…
US
Zimmer Surgical Inc recalls Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that…
Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area
FDA · DeviceZimmer Surgical IncUS Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA…Official notice →US
Blue Belt Technologies, Inc recalls Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational…
US
AB Sciex, LLC recalls Citrine Triple Quad Mass Spectrometer, Part Number 5063684
In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly…