Neurology › SurgicalNeurosurgical Paddie

Telfa

Telfa Strips 3/4" x 6"

Registry build 21.09.26
2manufacturers in China registered for this device type
13catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls on this code

Who Else Makes It

Concentrated in Hubei (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HBA
Manufacturer City Province Registered as Device types
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Allmed Industrial Limited Shenzhen Guangdong Manufacturer 42

Record

Regulatory record for Telfa
Listed by American Surgical Company, LLC, United States
FDA product code HBA
Device type Neurosurgical Paddie
Device class Class 2
Regulation 21 CFR 882.4700
Establishment Contract manufacturer, Manufacturer
510(k) K904514
Record published 2016-06-16
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Telfa
Catalogue number Size Per pack Status
80-05 20 In distribution
80-14 20 In distribution
80-22 20 In distribution
81-11 20 In distribution
80-04 20 In distribution
80-06 20 In distribution
80-11 20 In distribution
80-13 20 In distribution
81-13 20 In distribution
81-06 20 In distribution
80-09 20 In distribution
80-12 20 In distribution
80-08 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OMT LLC OMT, LLC 126
Neuray ® Medtronic Xomed, Inc. 63
Codman® Integra LifeSciences Production Corporation 42
Codman Cerenovus, Inc. 41
Americot American Surgical Company, LLC 39
Spetzler Neuro Patties OMT, LLC 35
Merocel Medtronic Xomed, Inc. 34
Ray-Cot American Surgical Company, LLC 26
Uniqcot American Surgical Company, LLC 24
Medline Medline Industries, Inc. 19
Zevo™ Anterior Cervical Plate System Medtronic Sofamor Danek, Inc. 17
Ultracot American Surgical Company, LLC 15

Showing 12 of 24. All products under Neurosurgical Paddie

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K112598 2013-06-20
K121822 2012-09-10

Recalls Naming This Product

7 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Telfa
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 11 boxes 2016-10-21
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 24 boxes 2016-10-21
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 4 boxes 2016-10-21
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 178 boxes 2016-10-21
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 7 boxes 2016-10-21
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 10 boxes 2016-10-21
American Surgical Company, LLC 510(k) number 2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 57 boxes 2016-10-21

Recalls

37 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2024-09-18 Class II Process control Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field. 390 units
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 343 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 4 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 442 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 3 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 21 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 7 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 24 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 99 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 165 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 4 cases 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 351 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 27 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 113 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 38 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 78 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 315 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 16 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 409 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 1 box 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 28 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 287 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 338 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 97 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 33 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 15 cases 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 165 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 3 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 3 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 209 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 689 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 39 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 5 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 27 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 3 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 449 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 68 boxes 2016-10-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer