Ritmed non-sterile neurological sponges may exceed endotoxin specification for cerebrospinal contact
Ritmed non-sterile Neurological Sponges across seven sizes are being recalled because they may not consistently meet the endotoxin specification for devices contacting cerebrospinal fluid.
What this means for you
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 a stated risk of neurovascular adverse events and febrile response from elevated endotoxin, a risk of harm with no injuries reported.
Plain-English summary
Ritmed Neurological Sponges, non-sterile, are being recalled across sizes including 0.5 x 0.5 in (REF 55992C), 0.5 x 1.0 in (55993C), 0.5 x 3.0 in (55994C), 0.75 x 0.75 in (55995C), 1.0 x 1.0 in (55996C) and 1.0 x 3.0 in, UDI-DI 20686864043205. The action covers 7,838,200 units distributed after 1 May 2022, spanning the lots listed in the recall notice.
The sponges are used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision. According to the manufacturer, they may not consistently meet the endotoxin specification for devices that contact cerebrospinal fluid, and elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension or nausea. The FDA classified the action as Class II.
Distribution was within the United States, in Montana, North Carolina, Virginia, California, Texas, Ohio, Tennessee, Illinois and Rhode Island.
Facilities should identify affected stock using the REF numbers, UDI-DI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by AMD Medicom.
The recalled product
- Product
- Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
- Manufacturer
- AMD Medicom Inc.
- Category
- Medical Device — Surgical sponge
- Affected units
- 7,838,200
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)
- UDI-DI: 20686864043205. Distributed After May 1st
- 2022
- including the following lots: 19316
- 16409
- 15463-7
- 15463-6
- 15463-5
- 15463-4
- 15463-3
- 15463-2
- 15463-1
- 15463
- 15192-1
- 15192
- 14813
- 14039
- 13673
- 13289
- 12641
- 12206
Distribution
Part of a larger recall action
This product is one of 2 recalled by AMD Medicom 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 2 products in this recall →Related recalls
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