MEDLINE INDUSTRIES, LP - Northfield recalls Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Read the official notice →- Date
- 2023-02-08
- Country
- United States
- Brand
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AR, MD, WA, 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More MEDLINE INDUSTRIES, LP - Northfield recalls
- 2023-02-22
USMEDLINE INDUSTRIES, LP - Northfield recalls Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-15
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS…
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Japan,…Official notice → - 2023-02-08
- US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
- 2023-02-01
- US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
The kit contained an expired component.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of NY, IN, FL, NJ, IL.Official notice → - 2023-01-18
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item…
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - 2022-11-09
- US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.Official notice →
Other drugs & medical recalls in the United States
- 2023-02-08
- US
Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - US
Turbett Surgical, Inc. recalls Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
FDA · DeviceTurbett Surgical, Inc.US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA,…Official notice → - US
Biomet, Inc. recalls OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone,…
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
- US
Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or…
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia,…Official notice → - US
SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Due to tears reported tears in the cannula due to wear and tear stress.
FDA · DeviceSynCardia Systems LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice → - US
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6)…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
FDA · DeviceSmiths Medical ASD Inc.Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR,…Official notice →