Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10ML…
Spectra Medical Devices, Llc · Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exp…
Open FDA's page for this record- Cfres ID
- 219763
- Product res number
- Z-2873-2026
- Event date initiated
- 2026-07-06
- Event date posted
- 2026-08-11
- Recall status
- Open, Classified
- Res event number
- 98777
- Product code
- NGT
- Firm FEI number
- 3000204727
- Recalling firm
- Spectra Medical Devices, Llc
- Address 1
- 299 Ballardvale St
- Address 2
- Ste 1
- City
- Wilmington
- State
- MA
- Postal code
- 01887-1066
- Additional info contact
- Kathy Dassler US-978-6570889
- Root cause description
- Nonconforming Material/Component
- Product quantity
- TBD
- Distribution pattern
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Product description
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
- Code info
Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.
- Reason for recall
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
- Action
On July 6, 2026, firm sent letters titled, "Urgent: Medical Device Recall" to customers. Customers were instructed to examine their stock for affected product and discard or return any unused Sodium Chloride Flush ampules from the identified lot numbers. For affected products already in distribution, customers should instruct downstream customers to discard or return unused product. Customers were also instructed to use extra vigilance in detecting and reporting potential patient health concerns that may be related to this product.
- K numbers
- K082689, K103740
- Harmonized identifiers (openFDA)
- Device name
- Saline, Vascular Access Flush
- Medical specialty description
- General Hospital
- Regulation number
- 880.5200
- Device class
- 2
- K number
- K121050, K042061, K161552, K231363, K173348, K231161, K250884, K111034, K214080, K133685, K213522, K233623, K032438, K191378, K223584, K082689, K121231, K231724, K192414, K142620, K082837, K101270, K171109, K120836, K060339, K113555, K103740, K020999, K141311, K011283, K231754, K020996, K121262, K230756, K091583, K090882, K150143, K153481, K183473, K201286
- Registration number
- 3004080548, 1224960, 3011508621, 3012421607, 3015751263, 3005806438, 1423507, 1526711, 3008518459, 3014421917, 3016972038, 1057300, 1650927, 3010407203, 1047843, 1043214, 1911916, 3015060216, 9680794, 3005669815, 3038181770, 3036706541, 3004756837, 1649518, 2243072, 3007163376, 2320762, 1423662, 3043709866, 3012494290, 3036113190, 1423982, 3002907620, 9616657, 3016741564, 3009848807, 3017509841, 3016413378, 3036757319, 2518902 +12 more
- FEI number
- 3004080548, 3011508621, 3012421607, 3015751263, 3005806438, 1526711, 3008518459, 3014421917, 3016972038, 3003040625, 3010407203, 3000215273, 1047843, 1043214, 1911916, 3015060216, 3005669815, 3038181770, 3002695476, 3036706541, 3004756837, 2243072, 1000112968, 3007163376, 3043709866, 3012494290, 3036113190, 3002907620, 3005698992, 1000112877, 3008002452, 3009848807, 3016741564, 1000151124, 3017509841, 3016413378, 3036757319, 3001236277, 1000122362, 2518902 +12 more