Medline Staple Remover Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling sterile staple remover kits because the iodine concentration is below the labeled 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 Severe rating under the rubric, particularly given the subpotent nature of the antiseptic agent in a sterile medical device.
Plain-English summary
Medline Industries, Inc. is recalling 600 cases of Medline Staple Remover Kits, Sterile, Single Use Only. 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 product is identified by Pack Number DYNDR1118 and Lots 17SB4219 and 175B2486. The products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare providers should stop using the affected staple remover kits and contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 600
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 (3)
- Pack Number: DYNDR1118
- Lots: 17SB4219
- 175B2486
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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