Medline Abdominal Surgery Packs Recalled for Low Iodine Content
Medline Industries is recalling Abdominal Surgery II Packs because the iodine content in the prep pads is below the label claim.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric.
Plain-English summary
Medline Industries Inc is recalling 144 cases of Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. The product is identified by Pack Number PHS541637005. The recall is due to the titratable iodine contained in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The agency has classified this recall as Class II.
Consumers and healthcare facilities should stop using the affected packs and contact Medline Industries Inc for further instructions or a refund.
The recalled product
- Product
- Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 144
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 (1)
- Pack Number: PHS541637005
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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