Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.
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: The recall is classified as FDA Class II and involves a sterile medical device with a compromised seal, posing a risk of infection (risk-of-harm product) without reported injuries or illnesses in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling Integra Drainage Accessory Kits, Catalog Number 910122, Lot #0195615, with an expiration date of 04/2019. The product is a sterile, prescription-only medical device used for intraoperative drainage of cerebrospinal fluid (CSF). The kits are packaged in Tyvek pouches, with five pouches per cardboard box.
The recall was initiated after a final sampling inspection revealed that one of the lots had a total incomplete packaging seal. This defect may compromise the sterile barrier of the product. The agency has classified this recall as Class II.
The affected product was distributed nationwide to Kansas only. No specific number of affected units is provided in the source text. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 1
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 (2)
- Catalog Number 910122
- Lot #0195615 with expiry 04/2019
Distribution
Part of a larger recall action
This product is one of 6 recalled by Integra LifeSciences Corp. under a single FDA (Devices) 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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