Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury or property damage reports, or in this case, a subpotent drug issue that may compromise patient safety.
Plain-English summary
Medline Industries, Inc. is recalling Medline Suture Removal Trays, Sterile, Single Use Only. The recall involves 98,901 cases of the product, which was packaged in Mexico by Medline Industries, Inc., in Mundelein, IL.
The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This is classified as a subpotent drug issue. The affected product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare facilities should check their inventory for the specific pack numbers and lot numbers listed in the recall notice. If the product matches the recalled lots, it should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 98,901
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)
- Pack Number: MDS708550
- Lots 17GB4997
- 17TB7125
- 17RB7896
- 17HB3784
- 17HB4133
- 17RB7895
- 17FB1724
- 17FB2572
- Pack Number: MDS708550H
- 17PB5544
- 16JB1135
- 16SB9345
- 17FB2571
- 16NB7654
- 17FB1721
- 16LB8439
- 16WB1269
- 16NB8410
- 15VB7079
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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