Dutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a product-content discrepancy (wrong gauge infusion line) that poses a risk of harm during surgical use. No illnesses or injuries have been reported.
Plain-English summary
Dutch Ophthalmic USA, Inc. is recalling 16 boxes of TDC Vitrectomy Pack VGPC 25g (Product Number 8525.201) due to a product-content discrepancy.
The affected surgical packs are labeled as containing 25-gauge infusion lines but actually contain 23-gauge infusion lines. This gauge mismatch means the device included in the package does not match what is printed on the label.
The recall affects products distributed in Alabama, California, Colorado, Florida, and Michigan. The affected lot number is 2000401997.
Healthcare facilities and patients that have received these packs should not use them and should contact Dutch Ophthalmic USA, Inc. immediately for return or replacement with the correct gauge infusion lines.
The recalled product
- Product
- The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
- Manufacturer
- Dutch Ophthalmic USA, Inc.
- Affected units
- 16
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)
- Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Distribution
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