Home / Recalls / Professional Disposables International, Inc / D-0764-2021

D-0764-2021 Class II Terminated

Recalled by Professional Disposables International, Inc — Woodcliff Lake, NJ

Recall Details

Product Type
Drugs
Report Date
September 1, 2021
Initiation Date
July 23, 2021
Termination Date
May 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,039 cases

Product Description

PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161

Reason for Recall

SubPotent: Out of Specification

Distribution Pattern

Distributed Nationwide in the US

Code Information

SKU S23125 Lot #'s 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393

Other recalls by Professional Disposables International, Inc

  • D-0570-2022 Class II — Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% (February 4, 2022)
  • D-0571-2022 Class II — Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 7 (February 4, 2022)
  • D-0572-2022 Class II — Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v (February 4, 2022)
  • D-0763-2021 Class II — PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional (July 23, 2021)
  • D-0760-2021 Class II — PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable Intern (July 23, 2021)
  • D-0759-2021 Class II — PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Internat (July 23, 2021)
  • D-0761-2021 Class II — PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable Inter (July 23, 2021)
  • D-0758-2021 Class II — PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Profe (July 23, 2021)
  • D-0762-2021 Class II — PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional D (July 23, 2021)