Hill-Rom Steriseal-Cannula Ophthalmic Recall Due to Dislodgement Risk
Hill-Rom is recalling Steriseal-Cannula Ophthalmic handpieces because the metal cannula can rotate and become dislodged from the plastic handpiece.
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 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 and involves a structural defect in a medical device that can cause the component to dislodge, posing a significant risk of injury during a procedure.
Plain-English summary
Hill-Rom, Inc. is recalling 66,691 units of the Steriseal-Cannula Ophthalmic Bi-Manual Irrigating/Aspirating Handpiece. The recall involves product numbers 157400, 257400, 157500, and 257500.
The recall is being issued because the metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. This defect poses a risk of injury to patients or medical professionals during use.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Michigan and Pennsylvania) and in Belgium, England, Italy, the Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon. Healthcare facilities and consumers should stop using the affected devices and contact Hill-Rom, Inc. for further instructions on replacement or return.
The recalled product
- Product
- Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
- Manufacturer
- Hill-Rom, Inc.
- Hazard
- Affected units
- 66,691
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 (4)
- Product #s: 157400
- 257400
- 157500
- 257500
Distribution
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