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 Reord

FDA recall notice · announced September 1, 2021 · Professional Disposables

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: Distributed Nationwide in the US
Lot/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
Quantity: 11,039 cases
Status: Terminated
Products in this recall event:
- PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192. (D-0762-2021)
- PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154 (D-0759-2021)
- PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185 (D-0761-2021)
- PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819- (D-0758-2021)
- PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208. (D-0763-2021)
- PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178. (D-0760-2021)
- 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 Disposabl (D-0764-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.