Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
Check against the official notice below — it lists the full affected range.
Owen Mumford USA, Inc. is recalling Unifine Pentips 5mm x 31G pen needles sold in 100-count packages because water may have compromised the product during packaging. These sterile, single-use pen needles are intended for subcutaneous injection. When exposed to liquid, the sterility of the device may be compromised, which may be visible as discoloring or yellowing of the protective seal.
The recall affects 2,660 cartons (266,000 pen needles) distributed nationwide across 27 states. The affected products have UPC #384703550018 and include Batch No. AN 3550, Lot No. 1705722.S846 or Batch No. AN 3550AC, Lot No. 1705122.S929. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Reason for recall: Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal. Distribution: US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV Quantity: 2,660 cartons (266,000 pen needles) Lot/code info: UPC #384703550018: Batch No. AN 3550, Lot No. 1705722.S846; Batch No. AN 3550AC, Lot No. 1705122.S929.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.