MEDLINE INDUSTRIES, LP - Northfield recalls Lab Kit, SKU DYLAB1018; Component No. 503581
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Read the official notice →- Date
- 2024-11-20
- Country
- United States
- Brand
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Lab Kit, SKU DYLAB1018; Component No. 503581
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 MEDLINE INDUSTRIES, LP - Northfield recalls
- 2024-12-04
USMEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF…
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AL, GA, MA, NJ, and PA.Official notice →- US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON…
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide. Bermuda, Canada, Panama, UAE, US Virgin IslandsOfficial notice → - 2024-11-20
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the state of TN.Official notice → - 2024-10-30
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY…
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION…
XXX
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama.Official notice →
Other drugs & medical recalls in the United States
- 2024-11-20
- US
Olympus Corporation of the Americas recalls Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX,…
Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Karl Storz Endoscopy recalls Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY,…Official notice → - US
Topcon Medical Systems, Inc. recalls The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of…
The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical…
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 50, Model Number: 718096
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Olympus Corporation of the Americas recalls Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product…
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the state of TN.Official notice →