Medical Convenience Kits Recalled Over Endotoxin Variability in Neurological Sponges
Windstone Medical Packaging is recalling 465 AMS medical convenience kits in connection with a Medicom recall of Ritmed Neurological Sponges due to potential endotoxin level variability.
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: This is an FDA Class II recall involving potential endotoxin variability in neurological sponges. No hospitalizations or injuries are reported in the source, so the risk-of-harm product criterion where injury has not yet been reported applies, giving a score of 3.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 465 units of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits. The affected products are listed under 17 part numbers, including ENT Packs, Rhinoplasty Packs, Spine Packs, Lumbar Lami Packs, Septoplasty Packs, Laryngoscopy Packs, Nasal and Sinus Packs, Major Packs, and Sinus Packs. The recall notice was initiated due to a Medicom Urgent Medical Device Recall of specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C, related to potential unexpected variability of endotoxin levels on the products.
The affected kits were distributed nationwide in the United States in Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Washington. The FDA has classified this recall as Class II.
Healthcare providers and users should check the part numbers, UDI numbers, and lot numbers listed in the recall notice to determine whether their kits are affected. The recall notice does not provide specific consumer instructions; users should contact Windstone Medical Packaging, Inc. for guidance.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6)…
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 465
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) Pack Number AMS10411B
- UDI B098AMS10411B0
- Lot Numbers: 219316
- 221418
- 225796
- 227963
- 229410
- 231465
- 232835
- 234875
- 236009. 2) Pack Number AMS10411C
- UDI B098AMS10411C0
- Lot Numbers: 237159
- 239012. 3) Pack Number AMS11963A
- UDI B098AMS11963A0
- Lot Numbers: 219232
- 221841
- 231180
- 233233
- 235232
Distribution
Part of a larger recall action
This product is one of 4 recalled by Windstone Medical Packaging, Inc. 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
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