Pro-Dex Inc recalls KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0…
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Pro-Dex
- Product
- KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0…
- Classification
- Class II
- Units
- US distribution to FL only.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Pro-Dex recalls
- 2023-07-12
USPro-Dex Inc recalls KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be…
- 2023-04-26
- US
Pro-Dex Inc recalls KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a…
Incorrect Unique Device Identifier/GTIN code was used on product.
Other drugs & medical recalls in the United States
- 2024-11-13
- US
Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package…
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
FDA · DrugDenison Pharmaceuticals, LLCProduct was distributed to two accounts that may have distributed the product…Official notice → - 2024-11-06
- US
West Pharmaceutical Services AZ, Inc. recalls Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030…
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
FDA · DeviceWest Pharmaceutical Services AZ, Inc.A U.S. Distributor, Progressive Medical Inc. (PMI) currently supplies the…Official notice → - US
Smith & Nephew Inc recalls smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur…
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution…Official notice → - US
Accriva Diagnostics, Inc. recalls AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to…
- US
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,…
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to state of Texas and OUS (foreign) to countries of: Spain,…Official notice → - US
King Systems Corp. dba Ambu, Inc. recalls AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.