Sanofi Genzyme Recalls Synvisc-One Injections Due to Bacterial Contamination
Sanofi Genzyme is recalling Synvisc-One injections due to contamination with Methylbacterium thiocyanatum. The recall affects 12,380 units distributed in 36 states.
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. Per the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by bacterial contamination of an injectable medical device) fall under the 'Severe' category (Score 4).
Plain-English summary
Sanofi Genzyme is recalling 12,380 units of Synvisc-One (hylan G-F 20), a medical device used for the treatment of knee osteoarthritis. The recall is being conducted because the product is contaminated with Methylbacterium thiocyanatum. The affected product is a 6mL injection delivered from a 10mL syringe, specifically Lot Number 7RSL021 with an expiration date of May 31, 2020.
The recall covers units distributed nationwide across 36 states. Synvisc-One is an elastoviscous fluid containing hylan A and hylan B polymers produced from chicken combs, administered as a single intra-articular injection.
Patients who have received this specific lot of Synvisc-One should contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is…
- Manufacturer
- Sanofi Genzyme
- Category
- Medical Device — Injectable
- Hazard
- Affected units
- 12,380
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: 7RSL021 Expiration Date: 2020-05-31
Distribution
Distributed nationwide across the United States.
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