DeRoyal Recalls Sterile Surgical Kits Due to Expired Prep Pads
DeRoyal is recalling 226 sterile surgical kits because the included povidone iodine prep pads do not support the 36-month expiration date listed on the label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling error regarding expiration dates, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
DeRoyal Industries Inc is recalling 226 sterile custom surgical kits. These kits contain a Covidien-Dover Irrigation Tray with Piston Syringe and Medline Aplicare Povidone Iodine Prep Pads. The affected products are labeled as Shoulder Arthroscopy Packs (89-8686.01, 89-8686.02) and Knee Arthro Packs (89-8687.01, 89-8687.02).
The recall was initiated because Medline Aplicare determined that the povidone iodine prep pads would not support the 36-month expiration date listed on the label. The kits were distributed to California and Missouri.
Healthcare facilities and consumers should stop using these specific kits and contact DeRoyal Industries Inc for further instructions or a return.
The recalled product
- Product
- DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack…
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 226
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 (16)
- (a) Lot number: 38527131 (b) Lot numbers: 41450075
- 41511034
- 42143982
- 44108769
- 44274020
- 44721168
- 45599133
- (c) Lot numbers: 38497294
- 38564514
- 40146320
- 40990651 (d) Lot numbers: 41668816
- 42839390
- 44080575
- 44871131
- 45715430
- 46232122
Distribution
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