DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads
DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
DeRoyal Industries Inc is recalling 5,946 units of sterile custom surgical kits. These kits contain Medline Aplicare Povidone Iodine Prep Pads that were subsequently recalled by Medline Industries for incorrect expiration dates. The affected products include various Incision and Drainage Trays, a Cricothyreotomy Ambulance Kit, and Plastic Packs.
The recall covers specific reference numbers and lot numbers distributed nationwide in Georgia, Indiana, Florida, and Pennsylvania. The primary issue is a labeling error regarding the expiration date of the povidone iodine prep pads included in the kits.
Healthcare facilities and consumers should stop using these specific kits and contact DeRoyal Industries Inc for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incis
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 5,946
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF 47-763.04
- Lot Numbers:42728139
- 42812373 b) REF 47-763.06
- Lot Numbers:43638080
- 44508341 c) REF 47-763.07
- Lot Number:44877040 d) REF 89-6752.01
- Lot Numbers:43183812
- 43959220
- 44484561
- 44514919 e) REF 89-6818.02
- Lot Numbers:42054787
- 42691241
- 43197966
- 43979458 f) REF 89-7212.04
- Lot Numbers:41684621
- 41957423
- 42302605
- 42623281
- 42699622
- 42982612
Distribution
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