Presource surgical kits recalled for syringe design defect risk
Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.
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 recall with no reported illnesses or injuries. The design defect in included syringes poses a risk of inaccurate dosing and device leakage, but actual patient harm has not been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource kits and trays supplied nationwide. The recalled products include 80 different catalog numbers across multiple product lines, such as angiography packs, cath lab packs, arteriogram packs, neuro arteriogram packs, CVL packs, accessory packs, and pediatric cardiac cath packs. A total of 136,753 units are affected.
The recall concerns Shenli syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd that are included within Merit Medical-supplied kit components that make up part of the Presource finished kits. The FDA determined that these syringes could contain a significant change or modification in design that may significantly alter the safety or effectiveness of the final kit product. This design defect could result in inaccurate dosing or a leaking device, creating a risk of patient harm.
Healthcare facilities that have received these kits should immediately stop using the affected products and contact Cardinal Health for instructions on return or disposal. The specific affected lot numbers for each catalog number are detailed in the original FDA recall notice. Patients who may have received treatment with these kits should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 136,753
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)
- 1) SAN13BS605
- UDI/DI (CS/EA) 50888439661574/10888439661576
- Lot Numbers: 358969
- 2) SAN13BS606
- UDI/DI (CS/EA) 50195594317339/10195594317331
- Lot Numbers: 683419
- 3) SAN13BS607
- UDI/DI (CS/EA) 50195594746986/10195594746988
- Lot Numbers: 866520
- 4) SAN13BS608
- UDI/DI (CS/EA) 50195594778772/10195594778774
- Lot Numbers: 887311
- 5) SAN13BS609
- UDI/DI (CS/EA) 50197106253227/10197106253229
- Lot Numbers: 39241
- 6) SAN13BS60K
- UDI/DI (CS/EA) 50887488801436/10887488801438
- Lot Numbers: 229810
- 262632
- 276480
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Cardinal Health 200, LLC 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
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