Avanos Medical, Inc. recalls Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL…
Sterile extension sets were distributed without an expiration date
Read the official notice →- Date
- 2022-11-16
- Country
- United States
- Brand
- Avanos Medical
- Product
- Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL…
- Classification
- Class II
- Units
- US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 2023-06-14
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Some of the ambIT kits were potentially distributed without an air in-line filter.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of Texas and…Official notice →- 2023-04-26
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Incorrect expiration date.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice →- 2023-03-22
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FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of Oklahoma…Official notice →- 2022-02-16
US
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The External Retention Bolster contained in the kit may be a larger diameter than the tube.
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Other drugs & medical recalls in the United States
- 2022-11-16
US
Canon Medical System, USA, INC. recalls Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550,…
After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in…
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Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may…
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Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
US
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