Unifine Pentips 5mm x 31G pen needles, packaged in 30 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 30-count packages because water may have compromised the product during packaging. These sterile, single-use pen needles are intended for subcutaneous injection, and exposure to liquid can compromise their sterility, which may be visible as discoloring or yellowing of the protective seal. The recall affects 708 cartons (21,240 pen needles) distributed nationwide across 27 states.
The affected products have UPC #384701150012 and include three specific batches: Batch No. AN 1150 with Lot No. 1705711.T098, Batch No. 1150REC with Lot No. 1705722.T099, and Batch No. AN 1150HEB with Lot No. 1705722.T100. The source document does not specify what action consumers should take regarding this recall.
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: 708 cartons (21,240 pen needles) Lot/code info: UPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.